INVESTIGATIONS OPERATIONS MANUAL 2025 CHAPTER 8

Chapter 8 – Investigations
8.1 - INVESTIGATIONS AND INSPECTIONS .............................................................................................................. 5
8.1.1 – BACKGROUND – WHAT IS AN INVESTIGATION? .........................................................................................................5
8.1.2 - INVESTIGATIONS, INSPECTIONS, AND FORM 482? – WHEN DO YOU ISSUE AN FDA 482? .................................................5
8.1.3 - EXTERNAL REQUESTS FOR INVESTIGATIVE INFORMATION – WHAT IF SOMEONE ASKS YOU ABOUT AN INVESTIGATION?.............5
8.1.4 - OFFICE OF CRIMINAL INVESTIGATIONS – WHO IS OCI?...............................................................................................5
[Link] - OCI Responsibilities .................................................................................................................................5
[Link] - Reports of Criminal Activity.....................................................................................................................6
[Link] - Liaison with Law Enforcement / Intelligence Community.......................................................................6
8.1.5 - TYPES OF INVESTIGATIONS – WHAT SITUATIONS LEAD TO INVESTIGATIONS? ....................................................................6
[Link] - Defective Products ..................................................................................................................................6
[Link] - Injury, Illness, Death................................................................................................................................7
[Link] - Criminal Investigations ...........................................................................................................................7
[Link] - Surveillance .............................................................................................................................................7
[Link] - Washouts ................................................................................................................................................8
[Link] - For Cause/Fact-Finding/Information Gathering .....................................................................................8
[Link] - Complaints ..............................................................................................................................................8
[Link].1 - Types of Complaints .......................................................................................................................................... 9
[Link].1.1 - Injury/Illness Complaints ........................................................................................................................... 9
[Link].1.2 - Non-Injury/Illness Complaints ................................................................................................................... 9
[Link].2 - Sources of Complaints – Who provides us with complaints?............................................................................ 9
[Link].2.1 - Consumer .................................................................................................................................................. 9
[Link].2.2 - Industry ..................................................................................................................................................... 9
[Link].2.3 - Confidential Source ................................................................................................................................... 9
[Link].2.4 - Whistleblower ......................................................................................................................................... 10
[Link].2.5 – Anonymous Complainant ....................................................................................................................... 10
[Link] - Disaster/Emergency Response - How do we protect the consumer during a disaster or emergency? .10
[Link].1 - Preparedness................................................................................................................................................... 11
[Link].2 - Safety............................................................................................................................................................... 11
[Link].3 - Response ......................................................................................................................................................... 11
[Link].3.1 - Use of Incident Command System (ICS) .................................................................................................. 12
[Link].3.2 - Management of Disasters without ICS .................................................................................................... 12
[Link].4 - Disaster Types ................................................................................................................................................. 12
[Link].4.1 - Floods ...................................................................................................................................................... 12
[Link].4.2 - Earthquakes............................................................................................................................................. 13
[Link].4.3 - Hurricanes and Tornadoes ...................................................................................................................... 13
[Link].4.4 - Chemical Spills, Hazardous Waste Sites, Wrecks..................................................................................... 14
[Link].4.5 - Fires, Explosions, Riots ............................................................................................................................ 14
[Link].5 - Bioterrorism .................................................................................................................................................... 15
[Link].6 - Embargoes....................................................................................................................................................... 15
[Link].7 - Field Operations .............................................................................................................................................. 15
[Link].8 - Field Examination and Samples....................................................................................................................... 16
[Link].9 - Product Disposition ......................................................................................................................................... 16
[Link].9.1 - Segregation.............................................................................................................................................. 16
[Link].9.2 - Destruction .............................................................................................................................................. 17
[Link].9.3 - Reconditioning......................................................................................................................................... 17
[Link].9.4 - Relabeling ................................................................................................................................................ 17
[Link] - Counterfeiting and Tampering..............................................................................................................17
[Link].1 - Reporting Contacts.......................................................................................................................................... 17
[Link].2 – Office of Field Operations and Response/ Office of Emergency Response (OFOR/OER) Responsibility......... 18

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[Link].3 - Coordination with Other Government Agencies ............................................................................................. 18

[Link].4 - Authority & Responsibility............................................................................................................................... 18
[Link].5 - Release of Information.................................................................................................................................... 19
[Link].6 - Investigation.................................................................................................................................................... 19
[Link].7 - General Procedures......................................................................................................................................... 19
[Link].8 - Sampling.......................................................................................................................................................... 20
[Link].8.1 - Tampering Cases ..................................................................................................................................... 20
[Link].8.2 - Counterfeiting Cases ............................................................................................................................... 20
[Link].9 - Complainants .................................................................................................................................................. 20
[Link].10 - Continuance of Investigation ........................................................................................................................ 21
[Link].11 - Refusals ......................................................................................................................................................... 21
8.1.6 - GENERAL INVESTIGATIVE TECHNIQUES – WHAT DO I DO DURING AN INVESTIGATION?.....................................................21
[Link] - Interviews..............................................................................................................................................21
[Link].1 - Preparation ..................................................................................................................................................... 21
[Link].2 - The Interview .................................................................................................................................................. 21
[Link].3 - Safety............................................................................................................................................................... 22
[Link].4 - Basic Information to Obtain ............................................................................................................................ 22
[Link] - Medical Records....................................................................................................................................23
[Link] - Sample Collection..................................................................................................................................24
[Link] - Internet Investigations ..........................................................................................................................25
8.1.7 - LOCATIONS FOR INVESTIGATIONS – WHERE DO YOU CONDUCT AN INVESTIGATION?........................................................25
8.1.8 - INTERNAL AND EXTERNAL ORGANIZATIONS INVOLVED - WHO ELSE WILL I ENCOUNTER DURING AN INVESTIGATION? WHY ARE
THEY INVOLVED? ..........................................................................................................................................................25
[Link] - Interagency Referral .............................................................................................................................25
[Link] - Intra-agency/Cross-Program ................................................................................................................26
8.1.9 - GENERAL INVESTIGATION REPORTING – HOW AND WHERE DO I REPORT MY INVESTIGATION?...........................................26
[Link] – Entering domestic and foreign investigation operations in eNSpect ...................................................26
[Link].1 - Investigation memo: format, content, endorsement, and routing ................................................................. 27
[Link] - Entering import investigation operations in SERIO...............................................................................27
[Link].1 - Import investigation memo: format, content, and endorsement ................................................................... 28
[Link] - Reporting complaints/follow-ups .........................................................................................................29
[Link] - Reporting information obtained from a confidential source ................................................................29
[Link] - Reporting investigations conducted during disaster response .............................................................30
8.2 - HUMAN AND ANIMAL FOOD INVESTIGATIONS ............................................................................................ 30
8.2.1 - COORDINATION .................................................................................................................................................30
8.2.2 - FOODBORNE ILLNESS OUTBREAK INVESTIGATIONS ....................................................................................................31
[Link] - Cooperation with Other Agencies .........................................................................................................31
[Link] - Outbreaks on Foreign Flag Vessels .......................................................................................................32
[Link] - Outbreaks Involving Interstate Conveyances........................................................................................32
[Link] - Outbreak Management ........................................................................................................................32
[Link] - Conducting Foodborne Illness Follow-up ..............................................................................................33
[Link].1 - Preparation ..................................................................................................................................................... 33
[Link].2 - Interviews........................................................................................................................................................ 33
[Link].2.1 - Conducting Interviews............................................................................................................................. 34
[Link].2.2 - Information to Gather ............................................................................................................................. 34
[Link].3 - Medical Records .............................................................................................................................................. 35
[Link].4 - Sampling Procedures....................................................................................................................................... 35
[Link].4.1 - Sample Collection .................................................................................................................................... 36
[Link].4.2 - Sample Size.............................................................................................................................................. 36
[Link].4.3 - Sample Handling...................................................................................................................................... 36
[Link].5 - Establishment Investigation ............................................................................................................................ 37

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[Link].5.1- Food Handlers Interviews......................................................................................................................... 38

[Link].6 - Possible Contamination Source....................................................................................................................... 38
[Link].7 – Conducting Traceback Investigations ............................................................................................................. 39
[Link] - Reporting ..............................................................................................................................................39
[Link].1 - Reporting Epidemiological Investigations ....................................................................................................... 39
[Link].2 - Reporting Food Adverse Events ...................................................................................................................... 40
[Link].2.1 - Food and Cosmetics ................................................................................................................................ 40
[Link].2.2 - Dietary Supplements ............................................................................................................................... 40
[Link].2.3 - Cosmetics ................................................................................................................................................ 40
[Link].2.4 - Veterinary Products................................................................................................................................. 40
[Link].2.5 - Reports of Criminal Activity..................................................................................................................... 40
8.2.3 - INJURY, ILLNESS, DEATH......................................................................................................................................40
[Link] - Procedures ............................................................................................................................................41
[Link] - Specific Product Reporting (Food, Dietary Supplement, and Cosmetic – Injury or Reaction) ...............41
[Link].1 - Dietary Supplements ....................................................................................................................................... 41
[Link].2 - Cosmetics ........................................................................................................................................................ 42
[Link].2.1 - Causes...................................................................................................................................................... 42
[Link].3 - Investigation Requirements for Serious Adverse Events of HFP Regulated Products ..................................... 43
[Link].4- Undeclared Allergen/Allergic Reactions........................................................................................................... 43
[Link] - Veterinary Products-Complaints/Adverse Reactions ............................................................................44
[Link] - Sample Collection..................................................................................................................................44
[Link].1 - Cosmetic Samples............................................................................................................................................ 44
[Link].2 - Microbiological Contamination ....................................................................................................................... 44
[Link].3 - Allergen Samples ............................................................................................................................................. 44
8.2.4 - SPECIAL EVENTS ................................................................................................................................................44
8.2.5 - FARM INVESTIGATIONS .......................................................................................................................................45
[Link] - Approach...............................................................................................................................................45
[Link] - Sampling ...............................................................................................................................................45
[Link] - Form 3623 Farm Investigation Questionnaire ......................................................................................46
[Link] - Reporting ..............................................................................................................................................46
8.2.6 - INFANT FORMULA AND BABY FOOD ......................................................................................................................46
8.2.7 - TAMPERING INVOLVING ALCOHOLIC BEVERAGES......................................................................................................47
8.3- DRUG INVESTIGATIONS ................................................................................................................................ 47
8.3.1 - INVESTIGATIONS COORDINATION ..........................................................................................................................47
8.3.2 - ILLNESS/INJURY .................................................................................................................................................48
[Link] - Reporting ..............................................................................................................................................48
[Link].1 - Reporting Forms – Drugs................................................................................................................................. 48
[Link].2 - Reporting Forms – Veterinary Products .......................................................................................................... 48
8.3.3 - COMPLAINTS ....................................................................................................................................................48
8.4 - DEVICE INVESTIGATIONS.............................................................................................................................. 49
8.4.1 - INJURY/ILLNESS .................................................................................................................................................49
[Link] - Types of device injuries or illnesses include: .........................................................................................50
[Link].1 - Mechanical, Electrical, or Electromechanical Devices..................................................................................... 50
[Link].2 - Devices for Implant ......................................................................................................................................... 50
[Link].3 - In-Vitro Diagnostic Devices.............................................................................................................................. 50
8.4.2 - CONFIDENTIAL SOURCES .....................................................................................................................................51
8.4.3 - COMPLAINTS ....................................................................................................................................................51
8.4.4 - REPORTING ......................................................................................................................................................52
8.4.5 – MEDICAL DEVICE SAMPLING ...............................................................................................................................52

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8.5 - BIOLOGICS INVESTIGATIONS........................................................................................................................ 52

8.5.1 - ILLNESS/INJURY .................................................................................................................................................52
[Link] - Reporting ..............................................................................................................................................53
[Link].1 - Investigation/Reporting .................................................................................................................................. 53
[Link].2 - Professional Reporting System for Vaccine Adverse Reactions ...................................................................... 53
8.5.2 - SURVEILLANCE ..................................................................................................................................................54
8.5.3 - CONFIDENTIAL INFORMANTS................................................................................................................................55
8.5.4 - COMPLAINTS ....................................................................................................................................................55
[Link] - Biological Products................................................................................................................................55
[Link] -Biological Samples .................................................................................................................................55
[Link] – Biological Injury/Adverse Reaction Reports .........................................................................................55
8.6 - BIORESEARCH MONITORING INVESTIGATIONS ............................................................................................ 56
8.6.1 - ILLNESS/INJURY .................................................................................................................................................56
[Link] - Reporting ..............................................................................................................................................56
8.6.2 - SURVEILLANCE ..................................................................................................................................................56
8.6.3 - COMPLAINTS ....................................................................................................................................................56
8.7 - TOBACCO INVESTIGATIONS.......................................................................................................................... 56
8.7.1 - INVESTIGATIONS COORDINATION ..........................................................................................................................56
8.7.2 - COMPLAINTS ....................................................................................................................................................56
8-1 - FEDERAL ANTI-TAMPERING ACT FULL LANGUAGE ................................................................................ 58
8-2 - LETTER TO HEALTHCARE PROVIDER FOR MEDICAL RECORDS ................................................................ 59
8-3 - INVESTIGATION MEMO ......................................................................................................................... 60
8-4 - TABLE OF INCIDENT COORDINATION..................................................................................................... 64
8-5 - CIFOR OUE AGENT LIST.......................................................................................................................... 66
8-6 - VAERS FORM ........................................................................................................................................ 74
8-7 - MEDWATCH FORM................................................................................................................................ 78
8-8 -POTENTIAL TOBACCO PRODUCT VIOLATIONS FORM ............................................................................. 81
8-9 – DISASTER RESPONSE FLOW DIAGRAM.................................................................................................. 84

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8.1 - Investigations and Inspections

8.1.1 – Background – What is an investigation?
An investigation is an information-gathering activity conducted for several reasons and this definition
applies across OII programs. The purpose of an investigation is to determine and document facts
concerning an issue to inform the agency in making sound decisions. Used informally, investigation can
apply to a very general activity. It may refer to a response to a more formal request for specific
information. Information obtained during an investigation may lead to other operations such as sample
collections or inspections.
This chapter contains specific information on many types of investigations, and each section provides
guidance on how to conduct those investigations, special reporting requirements, and where additional
assistance can be obtained. Recall work, a special type of investigation, is covered in Chapter 7. See IOM
8.1.9 on Reporting an investigation.

8.1.2 - Investigations, Inspections, and Form 482? – When do you issue an

FDA 482?
Investigations generally do not require an FDA 482, but there will be times when you need to issue an
FDA 482, such as when you are at a manufacturing site or doing work like an inspection (e.g., collecting
records at a manufacturer or shipper to document interstate commerce). Consult with your supervisor
to determine the proper course of action for these situations. Investigations may be performed at a
location not subject to FDA inspection.

8.1.3 - External Requests for Investigative Information – What if someone

asks you about an investigation?
Investigations will naturally lead to interest from outside groups. Consumers, industry, press, and other
external stakeholders may want information about your investigations. Do not reveal any information
about an investigation to anyone outside of the agency without express permission. Direct any requests
for information to the FDA’s How to Make a FOIA Request webpage ([Link]
information/freedom-information/how-make-foia-request). Refer all media inquiries to the OII Press
Office at OIIPress@[Link] (see IOM 1.7).
In the case of complaints where a sample has been collected from the complainant they may be
informed of FDA's findings when an examination is made of the sample. When you collect a sample from
a complainant, and they ask for analytical results, they may be told that the FDA will advise them of the
general nature of the findings. Enter the complainant’s contact information (name, address, phone
number and email) into the Collection Remarks section of the Collection Report. Be sure to consult with
your supervisor prior to collecting samples from a complainant. See IOM [Link] and IOM [Link]. The
Firm’s Home District Compliance Branch will notify the Complainant of the Sample results.

8.1.4 - Office of Criminal Investigations – Who is OCI?

[Link] - OCI Responsibilities
OII’s Office of Criminal Investigations (OCI) has the primary responsibility for all criminal
investigations conducted by the FDA, including suspected tampering incidents and suspected
counterfeit products. Similarly, OCI has primary responsibility — and is the primary point of contact
for — all law enforcement and intelligence matters.

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[Link] - Reports of Criminal Activity

All reports of suspected or confirmed criminal activity, including suspected tampering or
counterfeiting incidents, must be reported to the appropriate OCI field office or resident office
without delay. Additionally, all threats or perceived threats against FDA-regulated products are to be
referred immediately to the local OCI field office or to OCI headquarters. In those instances where
OCI does not, or cannot initiate a criminal investigation in a timely manner, the division offices will
consult with OCI to determine the proper follow-up.
[Link] - Liaison with Law Enforcement / Intelligence Community
OCI is the FDA's liaison with the law enforcement community for criminal investigations and related
matters. In addition, OCI serves as the primary point of contact between the FDA and the
intelligence community on all matters of mutual interest. OCI participates in numerous law
enforcement and intelligence task forces both nationally and internationally including as a full-time
representative at Interpol.
All contacts regarding requests or questions received from federal, state, or local law enforcement
agencies or intelligence agencies are to be referred without delay to the local OCI field office.
Similarly, law enforcement contacts to FDA headquarters or centers should be referred to OCI
headquarters.
When FDA personnel receive information or requests from law enforcement or other agencies, they
should obtain the caller's name, organization, and the details of the request. The caller should then
be referred to the appropriate OCI component. After referring the caller to OCI, contact the affected
OCI unit to provide the caller's information. This will prepare OCI of the expected contact. FDA
personnel should not respond to inquiries concerning criminal investigations, including questions
seeking confirmation of whether FDA is or is not conducting a criminal investigation.

8.1.5 - Types of Investigations – What situations lead to investigations?

You may conduct a variety of investigations in your career. Some types of investigations include, but are
not limited to complaint investigations, disaster investigations, health fraud investigations, and product
tampering investigations. When conducting any investigation, keep an open mind. Each investigation
will be unique.
[Link] - Defective Products
A defective product is one that fails to do what it is expected to do. For example, a diabetes
medication that fails to adequately control blood sugar levels that is prescribed for that reason. A
defective product will typically result in a recall where the product may be destroyed or
reconditioned.
Investigations into defective products could be initiated as a result of consumer or industry
complaints that may indicate the need for follow up with the consumer or industry representative,
which would be conducted as an investigation. Investigations are initiated to determine facts
surrounding a claim related to the status or disposition of a subject FDA-regulated product.
Subsequent findings would determine necessary follow-up and/or FDA action (e.g., inspection,
sampling, product recall).

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[Link] - Injury, Illness, Death

Escalation must occur when there is indication of a life-threatening injury/illness or adverse reaction
or death. Follow up may vary depending on the situation. You may be asked to conduct
investigations at complainants’ residences or at firms to investigate any potential causes for the
adverse reaction. Inspections at firms may also be warranted. These investigations could be
assigned by Office of Emergency Operations (OEO), the Coordinated Outbreak Response and
Evaluation (CORE) Network, or other agency components.
You may need to collect medical records or in some cases autopsy reports during these
investigations. (See IOM [Link] for guidance on obtaining medical records.)
When discussing complaints with a firm representative, do not provide any identifying information
of the complainant, for example, name, phone number, or city or state of residence. Reports of
adverse reactions may be received from consumers or health care professionals through voluntary
reporting such as MedWatch. Reports may be received from state or federal partners.
NOTE: Follow any program specific guidance related to investigation preparation, collection of these
records, etc.
[Link] - Criminal Investigations
During your work, you may encounter situations that involve criminal or fraudulent activity as
defined under Title 18 USC and Title 21 USC. Criminal activity noted by FDA consumer safety officers
(CSO) is typically cases of individuals and/or firms making false statements or providing false
documents during an inspection or other official activity. There are other violations of Title 18 and
criminal violations of Title 21 USC that you may encounter.
Fraud is a separate criminal act from false statements and involves a false representation of a
matter of fact whether by words or by conduct, including concealment of information, intended to
deceive another for advantage.
In all cases of criminal activity including fraud, OCI is the primary investigative office for FDA. Gather
as much initial information as possible and notify your supervisor. You may be asked to assist OCI in
its investigation. If so, follow their directions and do not discuss the investigation with anyone
outside of the investigation.
[Link] - Surveillance
During your inspectional, investigational, and other activities, be alert to anything which may be
new or unusual or interesting from FDA's viewpoint such as:
• New firms.
• New products.
• New production and distribution practices.
• New equipment and industrial processes.
• Seasonal practices.
• Industry trends.
• Recent or on-going construction and plans for future expansion.
• Proposed products.
• New ideas the firm is contemplating.
• New products in the development stage.

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• Activities about a firm's competitor.

• Plans for consolidation, mergers, diversification, etc.
If this information relates to a firm you are not currently inspecting, report the information using a
Memo of Investigation and route through your supervisor appropriately. If the information relates
to a firm being inspected report in the Establishment Inspection Report (EIR). (See IOM 8.1.9 for
details on reporting your investigation.)
[Link] - Washouts
A “washout” is defined as an operation where you are unable to complete an assigned inspection.
When you encounter a washout, you should determine the reason you are unable to conduct the
inspection. For example, a firm that operates seasonally may be available for inspection later in the
year. If a firm has moved, attempt to find the forwarding address of the firm. If the firm remains in
the local area, do not treat it as a washout but conduct the inspection at the new location. Each
washout should be investigated so that you are able to explain why you could not conduct the
inspection. (See IOM 8.1.9 for details on reporting your investigation.)
[Link] - For Cause/Fact-Finding/Information Gathering
A “for cause”, fact-finding or information gathering investigation is generally received by the division
from an outside source like a center, OII headquarters, or another division. It will generally be a
request to obtain specific information from a firm or other source. One example could be obtaining
interstate documentation from a shipper of a product to support a regulatory action, such as a
seizure in another division.
[Link] - Complaints
A complaint is a notification that a product may be in violation of the laws and regulations
administered by FDA. A complaint may be related to the following areas:
• Economic problems/misbranding (i.e., labeling).
o Short weight.
o Deceptive or misleading packaging and labeling.
o Fraudulent products.
• Filth, decomposition, foreign objects, microbial or chemical contamination
• Animal/plant/insect material.
• Off appearance, off odor, or off taste.
• Glass, metal, plastic, or other foreign objects.
• Bacteria, yeasts, molds, or fungi.
• Pesticides, industrial, or other chemicals.
• Defective products
o Sub potency or super potency.
o Particulate matter.
o Failure to operate as intended.
• Adverse reactions
o Allergic reactions.
o Expected reactions.
o Birth defects and problem pregnancies.
o Death.

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• Tampering
Complaints are received from various sources, including consumers, other government agencies,
Congress on behalf of their constituents, trade associations, etc. SOP-000544 – Consumer Complaint
Procedure describes the receipt and processing of consumer complaints in detail.
The Office of Field Operations and Response/ Office of Emergency Response (OFOR/OER), 1 (866)
300-4374 and [Link]@[Link], must be notified immediately of all death, life-
threatening injury/illness, and suspected tampering complaints. OFOR/OER must also be notified of
all complaints regarding infant formula/baby food. Advise OFOR/OER of the status of all such follow-
up investigations.
As unique situations arise, OER may provide guidance concerning the type of follow-up to be made.
[Link].1 - Types of Complaints
[Link].1.1 - Injury/Illness Complaints
A complaint indicating a life-threatening injury/illness, hospitalization, or death requires
immediate reaction. It may require immediate investigation.
There are additional considerations with life-threatening and non-life-threatening
injury/illness complaints. The prior medical history of the complainant may provide
indications regarding allergies, drug side effects or drug-food/drug-drug interactions which
may be responsible for the illness or injury. Medical verification should be sought in these
situations.
[Link].1.2 - Non-Injury/Illness Complaints
Generally, these do not require immediate follow-up at the consumer level. Follow-up may
include examining the parent lot, referral state, or local agency, or deferral until the next
regularly scheduled inspection. Examples include mold in beverages, obvious filth, or insects
in canned goods, etc. It may be possible that adequate investigation would be contacting
the dealer, advising them of the nature of the complaint and requesting notification of any
action taken. Non-injury/illness complaints do not need to be reported to the OEO unless
product tampering is suspected, or the product is a baby food or infant formula.
[Link].2 - Sources of Complaints – Who provides us with complaints?
Complaints come from many sources. Regardless of the source, all complainants should receive
a prompt and courteous response.
[Link].2.1 - Consumer
Consumers contacting field offices with complaints of injury, illness, or product defects
should receive a prompt, courteous response, and assurance that their complaints will
receive appropriate consideration. (See SOP-000544 – Consumer Complaint Procedure.)
[Link].2.2 - Industry
Industry complaints should be treated in the same manner as consumer complaints.
[Link].2.3 - Confidential Source
A Confidential Source is an individual who provides non-public information about an FDA-
regulated entity/product, alleging potential violation(s) of federal law, or an illicit or unsafe
product or activity, and who requests anonymity.
Note: The term “Confidential Informant” is used only by OCI in relation to criminal
investigations. Complaint Coordinators and Investigators use the term “Confidential Source”

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during the course of their work. It is important to avoid the disclosure of a confidential
source to a firm. The investigator conducting the investigation or inspection should not
disclose the complainant’s information or report the information in the EIR. The complaint
itself should be treated in the same manner as consumer complaints.
To maintain confidentiality, a memorandum regarding confidential information should be
submitted as a separate operation, linked to the original report or submitted as an
attachment to the EIR. There may be times when the report may be discussed in the EIR but,
it will not disclose the source of the information. Discuss with your supervisor before
including information obtained from a confidential source in the EIR.
[Link].2.4 - Whistleblower
A whistleblower is an individual who discloses information regarding an FDA-regulated
entity/product that the individual acquired during their current or former employment,
alleging potential violation(s) of federal law, or an illicit or unsafe product or activity. The
complaint itself should be treated in the same manner as consumer complaints. It is
important in these types of complaints that the identity of the whistleblower is not
disclosed. The investigator should follow the same protocol as dictated in the Confidential
Source section above by not disclosing the complainant’s information or reporting the
information obtained from the whistleblower in the EIR or any format where the
complainants’ information could possibly be released under the Freedom of Information
Act.
[Link].2.5 – Anonymous Complainant
An Anonymous Complainant is an individual, usually a consumer or someone on behalf of
consumer, who contacts FDA with concerns and provides information that a product in
commercial distribution may be in violation of the laws and regulations administered by FDA
and requests anonymity.
[Link] - Disaster/Emergency Response - How do we protect the consumer
during a disaster or emergency?
The objective of FDA investigations in the aftermath of disasters is to determine whether foods,
drugs including biologics, cosmetics, and devices affected by the catastrophe are safe for human and
animal use; and if not, to effectively have them removed from commerce.
In disaster operations, FDA may assist state, local, and other federal agencies in removing
contaminated or unfit merchandise from the market.
State and local officials usually assume direct responsibility for facilities and products under their
jurisdiction, as their laws and regulations can be immediately invoked; however, FDA assistance is
sometimes requested. Based on the size and scale of the disaster, FDA may receive an official
request for assistance through FEMA, FDA/state Rapid Response Teams, or ad hoc through
traditional state contacts.
If contacted by emergency response personnel for follow-up assignments, please work with your
supervisor to engage district Emergency Response Coordinator (ERC) for further coordination.

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[Link].1 - Preparedness
Disaster preparedness is the first step to ensure personal safety and response efficiency.
Measures taken to prepare for and reduce the effects of disasters both personally and
professionally are crucial before an incident occurs.
It is recommended as a preparedness measure that you familiarize yourself with your
local Continuity of Operations Plan (COOP). COOP is the initiative that ensures that
federal government departments and agencies can continue operation of their essential
functions under a broad range of circumstances including all-hazard emergencies, natural, man-
made, and technological threats, and national security emergencies. Today's threat
environment makes COOP planning even more critical. Your local COOP will alert you to likely
disasters for your geographic area.
Preparedness Resources:
• FDA’s Emergency Operations Plan
• FEMA Preparedness ([Link])
[Link].2 - Safety
OII considers the safety of staff to be of the utmost importance.
In a disaster or pending disaster the personal protection of yourself and your family is
your primary concern. Provide for your own safety as you perform your assigned FDA
duties in a disaster area. Inoculations and protective clothing should be considered. See
IOM Chapter 10-Safety. Particularly 10.8.1 - General Preventive and Protective Measures, IOM
10.17.2 -Immunizations, and 10.9- PPE. Contact the Occupational Health Services Staff for
further assistance.
Disasters produce dangerous situations (e.g., high water, escaping gases, fallen electrical lines,
damaged buildings, falling rubble, etc.), so care and extra safety precautions must be observed.
A Personal Safety Plan may be developed when dealing with disaster situations.
Be aware of hazards you may encounter while traveling in an affected zone such as power
outages, damaged or impassable roads, and a lack of available supplies in the area.
Personal Protective Equipment (PPE) should be considered where appropriate. For example,
appropriately fit-tested respirators such as N95 masks should be worn where there is a risk of
inhaling pathogens. Each situation requires a careful evaluation and determination of effective
PPE. Your supporting industrial hygienist should be consulted for guidance.
Safety Resources:
• Regulatory Operations Safety Staff (ROSS) Contacts
• ROSS Radiation and Laser Safety Resources
[Link].3 - Response
CAUTION: Although procedures in this subchapter do not cover disasters resulting from
a radiological event (presence or release of radioactive materials), it is possible you
may discover products suspected of contamination by radioactive materials in the
disaster area. If you suspect the presence of radioactive materials, take no action on
the materials yourself, but have the area cordoned off at once. Notify the command
official (official in charge) and immediately contact your IMT or supervisor, as applicable, to alert

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the radiological health representative and the state radiation control agency. Follow their
instructions.
[Link].3.1 - Use of Incident Command System (ICS)
During some disasters, FDA may implement an Incident Command System (ICS) for
response. ICS is a standardized approach to managing incidents at the on-scene level. It is
the combination of procedures, personnel, facilities, equipment, and communications
operating within a common organizational structure. ICS is scalable and flexible and can be
used for small, as well as large and complex, incidents and planned events.
As a CSO, you will typically be assigned under the Operations Section of the Incident
Management Team (IMT). All operations you conduct, and your reporting structure will be
provided by the IMT and shared via an Incident Action Plan (IAP). An IAP contains the
incident objectives, the overall strategy for managing an incident, personal safety guidance,
a comprehensive listing of the tactics, resources, and support needed to accomplish the
objectives. (Note: Some CSOs with ICS position specific training may serve in a leadership
role on the IMT.)
While serving on an IMT, your reporting will be to your team leader and not to your
supervisor. The IMT will provide specific guidance for reporting. Your activities will be
reported through the IMT and not through normal channels. Reporting may vary depending
on the incident and its objectives. You will not be following reporting guidance later in this
chapter.
[Link].3.2 - Management of Disasters without ICS
Specific investigation assignments should come from your supervisor and reporting will be
through the normal means, unless directed otherwise.
Response Resources:
• Disaster Response Flow Diagram (DRFD) package (Exhibit 8-9)
• Incident Management Handbook (IMH)
• Emergency Operations Plan (EOP)
• Homeland Security Presidential Directive 5
[Link].4 - Disaster Types
The types of natural and man-made disasters that affect FDA operations are:
[Link].4.1 - Floods
All flood water, regardless of its source, must be considered a polluting medium because of
overflowing sewers, outhouses, decomposing livestock, street run-off water, etc.
Depending on the extent of the flood, first determine the locations of the major stocks of
regulated products. Food and drugs will normally receive first priority. As stocks of goods
are located, rapidly survey the extent of damage, then concentrate on affected materials.
Use your camera extensively. Examine the walls of buildings, storage areas, and the top and
sides of stacked or tiered goods for flood water residue, debris, and a well-defined high-
water mark. Finished products, ingredients, and containers stacked above this line are still
of concern because other problems probably exist (e.g., vermin defilement, failure of
refrigeration, thawing of frozen items, etc.).

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Any suspect material should be embargoed by local officials or held pending final
disposition. Management is usually cooperative and willing to do things it may not normally
do to get back to normal operations as quickly as possible. Cooperate with management but
avoid hasty decisions.
Many products are quickly rendered unsuitable for human consumption by flood water.
Items such as bread, cakes, cookies, candies, bulk flour, sugar, bulk liquids, and similar items
not in jars or hermetically sealed containers can often be immediately hauled to disposable
areas and destroyed.
Determine areas which have lost power. In facilities such as frozen food firms, and frozen or
refrigerated warehouses, check the sites for length of down-power and condition of the
products. If power is restored in time to avoid thawing, or prevent spoilage of refrigerated
items, and products were not inundated, or otherwise affected, there is no need for further
examination.
Even though flood waters may not have inundated the firm, the situation may have caused
sewer and waste lines to backflush into basements and immediately drain out again. Debris
or sewage particles along walls and on low floor surfaces or presence of sewage odors are
evidence of backflushing.
Grain, cottonseed, soybeans, dried bean products, peanuts, and similar products may
become flood damaged in terminal elevators, on farms, and in flat storage facilities. In
addition to flood water contamination, molding products may develop mycotoxin
contamination. Examine susceptible products and facilities for damage, inundation, and
mold.
Rodent activity may increase in flooded areas as the vermin seek food and shelter. Be alert
to rodent defilement on products.
As lots of products are checked, embargoed, or released and the immediate situation
returns to normal, firms will want to start operating. Prior to beginning operations, examine
equipment and processing facilities for pollution and its aftermath. Plant operation must not
be permitted unless proper cleanup and sanitizing is performed.
[Link].4.2 - Earthquakes
Extreme care must be exercised when working in earthquake areas. Do not enter
severely damaged buildings.
Most damage from an earthquake comes from the aftershocks, falling debris, and
resulting fires and flooding. Items under FDA jurisdiction are most likely to suffer
physical damage, spoilage from lack of refrigeration, and/or fire and flood damage.
[Link].4.3 - Hurricanes and Tornadoes
Investigate following the guidance in Flooding section above. In addition, examine products
for evidence of physical damage caused by flying objects and crushing by debris. Physical
damage to product containers may be extensive. Broken or leaking containers of materials
such as chemicals, oils, fertilizers, etc., may have contaminated FDA-regulated products. See
the Chemical Spills, Hazardous Waste Sites, Wrecks section below on chemical
contamination from various sources.

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[Link].4.4 - Chemical Spills, Hazardous Waste Sites, Wrecks

Chemical spills occurring on land or water can pose a serious threat to the environment and
contaminate FDA-regulated products both directly and indirectly. See IOM 9.2.12 for
information.
In wrecks, the physical impact usually causes most damage. Toxic items in the same load
may rupture and add to the contamination. In train wrecks, other railcars loaded with
chemicals, oils, or other contaminating materials may rupture and contaminate food and
drug products in otherwise undamaged cars. Removal of the wreckage may cause further
physical damage or chemical contamination. Exposure to weather may also adversely affect
the products.
Do not overlook the possibility that runoff of toxic chemicals from wrecked and ruptured
cars may contaminate adjacent or nearby streams supplying water to downstream firms
under FDA jurisdiction.
Hazardous waste sites also pose a hazard to the immediate environment and other locations
off-site, if runoff contaminates nearby surface waters or, if leachate, contaminates ground
water supplies.
[Link].4.5 - Fires, Explosions, Riots
FDA operations following these disasters are usually localized and do not normally involve
many personnel or extended resources.
Examine products for exposure to excessive heat, physical damage from flying objects,
falling debris, and lack of refrigeration in down-power areas. Examine for water damage
from firefighting activities and handle these as a flooding situation. Be alert for possible
pollution from using non-potable water in firefighting.
Firefighting often involves use of chemicals. Examine products for residues from possible
toxic fire extinguishing materials and question fire authorities regarding this issue.
In addition, chemical contamination in fire disasters can also be present from other sources,
including:
1. Stored chemicals rupturing from heat or from impact of falling debris.
2. Spraying or leaking chemicals (liquid, powder, dust, granules) as damaged
containers are being removed or salvaged from the fire area.
3. Tracking of chemical material from contaminated areas to other areas by fire crews
or others.
4. Burning or melting plastic containers, insulation, and other building materials.
5. Leaking fuels, storage batteries, anti-freeze, etc., from burning, damaged or
overheated equipment.
6. Chemicals from melting or vaporizing electrical insulation and, in particular, cooling
chemicals from leaking or exploding electrical transformers. Large commercial
transformers are often directly involved in the fire area and may leak or explode
from the heat, spreading toxic liquid chemicals (some transformer oils contain
con-centrations of PCB) over a large area, even contaminating products in non-fire
areas.

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[Link].5 - Bioterrorism
The field was issued guidance from 2001 which includes the following:
If a bioterrorism act is suspected, FDA staff should not collect or accept samples from any local,
state, or law enforcement agency as such actions will be coordinated by OCI and the FBI, as
appropriate. If an FDA-regulated product is suspected in a tampering, please call OEM/OEO
immediately. In the FBI/OCI determines the product is not suspect, OEM/OEO will issue further
guidance to the division office.
Office of Field Operations and Response/ Office of Emergency Response (OFOR/OER)emergency
operations 24-hour phone number is 1 (866) 300-4374. The e-mail is
[Link]@[Link].
For additional information see Guidance to the Field on Bioterrorism (10/17/2001).
[Link].6 - Embargoes
See IOM 9.3.1 and IOM 3.7.1.
FDA does not have embargo authority, but does have administrative detention authority as
specified in:
• The Federal Meat Inspection Act ([Link]
acts/federal-meat-inspection-act)
• The Poultry Products Inspection Act ([Link]
acts/poultry-products-inspection-act)
• The Egg Products Inspection Act ([Link]
acts/egg-products-inspection-act
• Certain parts of the FD&C Act, namely Section 304(g) [21 U.S.C. 334(g)] for medical
devices, drugs, and tobacco and Section 304(h) [21 U.S.C. 334(h)] for human and animal
food
States and local jurisdictions have embargo authority over FDA-regulated products. Embargoes
are an effective tool for keeping adulterated and misbranded products from the consumer
market. State and local embargoes can be employed immediately requiring the merchandise be
held, destroyed, or reconditioned without time consuming delays. Some state and local
embargo powers are limited to the length of time the product can be embargoed and a minimal
quantity or value. In these cases, the use of federal administrative detention, injunction, and
seizure action should still be considered. Your division will determine if embargoes are
warranted and work with state or local authorities to obtain them.
[Link].7 - Field Operations
On-site inspectional and investigational activities will normally be conducted with other FDA
personnel and state or local counterparts.
An assessment must first be made of the disaster area to determine the extent of damage, and
the amounts and kinds of merchandise involved. This may be done by contacting local
Emergency Operation Centers on current conditions, and from firm and mapping details of the
impacted area provided by the OII Geographic Information System (GIS). If an IMT is activated
the Planning Section and Safety Officer will perform this assessment.
Whether operating within an IMT or not, once personnel are mobilized and assignments are
issued, operational procedures will be similar, regardless of the type of disaster. Normally, you

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will search, identify, and investigate foods, drugs, devices, and cosmetics for actual or possible
contamination and taking the necessary steps to preclude their use until they are released,
reconditioned, or destroyed.
CAUTION: Although procedures in this subchapter do not cover disasters resulting from a
radiological event (presence or release of radioactive materials), it is possible you may
discover products suspected of contamination by radioactive materials in the disaster
area. If you suspect the presence of radioactive materials, take no action on the
materials yourself, but have the area cordoned off at once. Notify the command official
(official in charge) and immediately contact your IMT or supervisor, as applicable, to
alert the radiological health representative and the state radiation control agency. Follow their
instructions.
When in doubt as to the condition of any materials affected, request holds or embargoes
pending final outcome of further examinations. See IOM [Link].6.
[Link].8 - Field Examination and Samples
Field examinations are an effective tool for determining adulteration or misbranding during
disaster investigations. Judge the extent of field examination and sample collections necessary,
based on the nature and magnitude of the disaster.
In major catastrophes, large numbers of samples may not be necessary because of obvious
visible contamination and the emergency disposition powers invoked by state and local officials.
In minor local disasters, such as fires, riots, train wrecks, truck accidents, or shipwrecks, lots may
be held pending outcome of examinations and extensive sampling may be required.
Field examinations should focus on obvious adulteration, such as physical damage to products
or containers, or damage to labeling.
Examine bulk containers and their contents, including underground storage tanks. Examine
material in rail cars, truck trailers, and storage silos. Be especially alert for rail car and trailer
movement. These may quickly disappear, as clean-up crews arrive.
[Link].9 - Product Disposition
Lots under embargo, or voluntarily held pending examination or analysis, must be secured until
the examination or analysis is completed, and a release decision is made. If the material can be
released, it is returned to the owner.
Depending on the circumstances and the magnitude of the disaster, segregation, destruction, or
reconditioning of affected goods may be accomplished in the immediate area or the materials
may be moved to distant locations for further manipulation.
FDA normally opposes movement of affected goods since control of the lots is difficult.
However, in cases of widespread disasters, reconditioning centers established in non-disaster
areas may be the most efficient way to handle the problem.
[Link].9.1 - Segregation
The segregation process often creates a multitude of problems, especially when insurance
claims agents and salvage firms become involved. You are not to segregate materials
yourself. This is the responsibility of the owner or his agent. You should advise them what
constitutes releasable conditions. After segregation, you may be instructed to advise them
about product release based on your examination and/or laboratory results.

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[Link].9.2 - Destruction
It is not your responsibility to say how condemned products are to be destroyed. This is a
concern of the owner and the state or local health agencies that condemned the products.
FDA may be asked to aid in or recommend destruction methods. The most common
destruction method is crushing and dumping in a land fill in approved areas. See IOM 3.9.1.
Destruction methods usually are worked out with state or local officials. The final decision in
major operations may be required of the command officials or higher headquarters,
especially if the environmental impact is significant.
Control products to be destroyed and protect them from pilfering at destruction sites.
[Link].9.3 - Reconditioning
Affected products may often be reconditioned depending on the condition of the product,
its container, type of product, intended use, and extent and type of contamination.
Any reconditioning must be closely supervised, with proper safeguards for product
accountability. Control must be maintained over the complete operation, with proper
disposition of the rejected portion and the reconditioning of the acceptable portion
performed to the satisfaction of all health officials.
Certain food products which cannot be salvaged for human or animal use might be of use in
non-food or non-feed industries. However, these must be denatured to render them unfit
for food or feed use. Firms must account for the amounts of product denatured, to whom it
was sold, and the final use of the product. Examination of the product at its final destination
and/or a spot check may be required to assure it is utilized in non-food or non-feed
products. Reconditioning plans should be reviewed by the Office of Compliance and
Enforcement in consultation with the appropriate center or by the IMT if ICS is being used
for the incident.

It is your responsibility to assure the firm is following the reconditioning plan and that no
product is diverted from the plan.
[Link].9.4 - Relabeling
Relabeling may be the only reconditioning required if damage is solely to the label and all
the following conditions are met:
• The new label contains all mandatory information, is not misleading in any way
conforms with the FD&C Act in all other aspects.
• Label codes are carried over to the new label.
• The product is not contaminated.
• The container has its original integrity.
[Link] - Counterfeiting and Tampering
[Link].1 - Reporting Contacts
All reports of counterfeiting, tampering, or tampering threats must be immediately reported to
the Office of Criminal Investigations (OCI) headquarters office, Special Agent in Charge-
Headquarters Operations at 240-276-9500 and the Office of Field Operations and Response/
Office of Emergency Response (OFOR/OER) at 1 (866) 300-4374 (24 hours); or through CMS
following SOP-000544.

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If the complaint or report involves a United States Department of Agriculture (USDA) regulated
product, the district office should report it directly to the USDA and notify OCI, SAIC-HQS OPS,
and OEM/OEO immediately. Notification of OCI may be done online at OCI’s Report Suspect
Criminal Activity website: ([Link]
OEM/OEO can be notified by e-mail at [Link]@[Link] and by phone 24
hours a day at 1 (866) 300-4374.
Do not conduct any investigation into these reports unless you have been directed to do so by
management following their meeting with OCI.
[Link].2 – Office of Field Operations and Response/ Office of Emergency Response
(OFOR/OER) Responsibility
OFOR/OER is the focal point for communications; especially in those counterfeiting/tampering
cases where regional/national coverage is necessary. Alert OFOR/OER immediately to all
suspected or confirmed counterfeiting/tampering incidents, whether or not there is an
injury/illness involved, especially if media attention will be initiated by any source.
[Link].3 - Coordination with Other Government Agencies
The Federal Bureau of Investigations (FBI) and the USDA share enforcement of the Federal Anti-
Tampering Act (FATA) with FDA as described below:
1. FBI Responsibility - The FBI has concurrent jurisdiction under the FATA over products
regulated by FDA. The FDA understands the FBI's primary interest in the FATA matters
will be to investigate; particularly, those cases which involve a serious threat to human
life or a death. SAIC-HQS OPS or the local OCI field office will coordinate all referrals to
the FBI in accordance with agency policy.
2. USDA Responsibility - The USDA will investigate and interact with the FBI on
counterfeiting/tampering of products regulated by USDA. If a counterfeiting/tampering
complaint or report is made to an FDA district office and involves a USDA-regulated
product, the district office should report it directly to the USDA and notify OCI, SAIC-
HQS OPS, and OEM/OEO immediately. Notification of OCI may be done online at OCI’s
Report Suspect Criminal Activity website.
Isolated incidents of counterfeiting/tampering not investigated by OCI and not meeting the
criteria for FBI or USDA follow-up, may be referred to the appropriate state or local investigative
agencies, as outlined in IOM [Link].4. The appropriate center should be consulted in these
cases. Assistance should be provided to cooperating officials as necessary or where requested.
[Link].4 - Authority & Responsibility
FDA is authorized to investigate reported counterfeiting/tampering of FDA-regulated consumer
products under the FATA, 18 U.S.C. Section 1365 and 18 U.S.C. Section 2320. See IOM Exhibit 8-
1. In most cases, the authority for such investigations is also found in the FD&C Act.
OCI has the primary responsibility for all criminal investigations of
counterfeiting/tampering/threat incidents of FDA regulated products. Given that responsibility,
OCI field offices will coordinate responses to counterfeiting/tampering reports with the district
offices they deem appropriate, to ensure initial investigative steps are taken in a timely and
efficient manner.

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In those incidents where OCI does not, or cannot, initiate a criminal investigation,
they will inform the division of their decision and the division will determine the
proper follow-up, which could include further investigation by the division or referral
to local or state authorities. The division will keep OCI informed of their follow-up
activities and any relevant changes in its status. Prior to initiation of any tampering
investigation, you and your supervisor should evaluate the situation from a personal safety
perspective. You and your division management may also need to determine if a situational plan
is warranted. Refer to IOM 5.3 – Safety during inspections and IOM Chapter 10 - Safety, for
more information.
[Link].5 - Release of Information
During any investigation related to counterfeiting or tampering, no information should be
released without management approval. If there are inquiries about the investigation, contact
your supervisor.
[Link].6 - Investigation
The purpose of these investigations is to determine if counterfeiting/tampering has occurred;
the seriousness of the problem; the quantity of affected products on the market; the source of
the counterfeiting/tampering; and quick removal from consumers or commerce of any
contaminated product. OCI will seek to identify and initiate criminal prosecution of those
persons responsible for criminal activity associated with counterfeiting/tampering/threat
incidents.
FDA will investigate reports of counterfeiting/tampering associated with FDA-regulated
products. Priority will be given to reports of death, illness, injury, or a potential health hazard.
Adhere to existing procedures and instructions as outlined in the IOM and RPM when
conducting counterfeiting/tampering investigations, inspections, sample collections, special
investigations, and related activities including interviews, record examination, direct
observation, affidavits, etc.
[Link].7 - General Procedures
Counterfeiting/Tampering incidents historically have occurred in unpredictable forms and
products. Standard operating procedures (SOPS), in most cases, will suffice for these
investigations. As events take place, specific instructions for some investigations may be
provided by OCI headquarters and/or your division office. Expeditious resolution is important,
especially when a health hazard may be involved.
Attempt to answer the following questions as rapidly as possible:
• Has counterfeiting/tampering occurred, or can the condition of the product be
explained by other means?
• Is death, injury, or illness associated with the report and, if so, does it appear to be
caused by the product counterfeiting/tampering?
• Does the incident appear to be isolated or wide-spread?
• Is it likely other, similarly affected FDA-regulated products remain in distribution, and if
so, what is the extent and magnitude of distribution?
• If the incident involves more than a single container, could counterfeiting/tampering
have occurred at the production facility or in the distribution chain rather than at retail?

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• Can specific persons or points in the distribution chain be identified as possibly causing
the problem?
Be sure to coordinate your efforts with OCI SAIC/IOD HQS OPS and OFOR/OER.
In many counterfeiting cases, OII investigators and OCI agents conduct joint
inspections/investigations at the distributors. It is the purpose of the OII investigators to
document receipt and distribution of counterfeit products and to discuss voluntary recall of
those products. OCI agents will at the same time conduct their investigation into the knowledge
and source of the counterfeit products. It is not your purpose to accompany the OCI agent
during his/her investigation.
[Link].8 - Sampling
[Link].8.1 - Tampering Cases
Whenever a sample is collected for suspected tampering, you must collect an authentic
sample of the same product. It should be from the same lot and code, if at all possible. The
sample size for the authentic portion is at least six in-tact units. Follow normal sampling
techniques; however, recognize that there may be forensic evidence available such as
fingerprints and hair that can be lost if the sample is not handled properly.
The Forensic Chemistry Center should be contacted prior to sampling. They can give specific
directions regarding sampling in each situation, especially related to the preservation of
forensic evidence like fingerprints.
Samples should be packed to avoid movement of the product container within the bag.
Individual dosage units from previously opened containers can be protected by
removing them from their container utilizing spoons or forceps. Secure them in
separate containers so they do not rub or smear possible evidence. Further
guidance can be found in the FBI "HANDBOOK OF FORENSIC SERVICES". As a
precaution, rubber gloves may be worn inside of cotton gloves as protection
against toxic or caustic substances.
Ship samples with extreme care to ensure their integrity. Thoroughly describe your sample
and its characteristics on the collection report (C/R) to facilitate analysis. Include any
descriptive terms used by individuals associated with the complaint. If special instructions to
preserve fingerprints or for further handling are indicated, they should be noted on the C/R.
If speed is imperative, consider hand delivery to the lab.
[Link].8.2 - Counterfeiting Cases
If sampling is indicated during an investigation of counterfeiting, follow the directions from
OCI or the Forensic Chemistry Center regarding collection, packaging, and shipment of the
sample. Authentic samples should only be collected when requested by OCI in consultation
with FCC.
[Link].9 - Complainants
Some complaints about “foreign objects” may be tampering complaints. The complainant may
state they found something in a product. You should be aware that any complaint investigation
of foreign objects may become a tampering investigation.
Consumers are likely unaware of the provisions of the Federal Anti-Tampering Act (FATA). A
general discussion of the FATA, its provisions for investigation, filing of false reports, and

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counterfeiting/tampering can be useful and informative to those individuals. Consumers are

often unaware that merely filing a false report is a serious crime and once aware may rescind
previous statements. In general, this would close an investigation, but you should discuss this
with your supervisor.
Prior to concluding your interview of the complainant, obtain a signed affidavit attesting to the
circumstances of the complaint, as directed by IOM 4.4.5. Include a statement in the affidavit
similar to the following, "I have been informed of the provisions of the Federal Anti-Tampering
Act and also that the providing of false information to the federal government is illegal." It is
permissible to pre-type this statement at the bottom of an affidavit, FDA 463a, and photocopy it
before use if you have many counterfeiting/tampering complaints to investigate.
[Link].10 - Continuance of Investigation
Some investigations may continue after the interview and sample collection from the consumer.
If you are directed to continue the investigation at the retail, distribution, or manufacturing
sites, obtain specific guidance from your management or OCI before proceeding. You may be
conducting an inspection at a firm simultaneously with an OCI investigation. You should not
disclose to the firm officials anything about an OCI investigation.
[Link].11 - Refusals
All refusals encountered during counterfeiting/tampering investigations should be documented
using existing procedures. Refusals of requests should be documented in detail. Assure the firm
is aware of the non-routine nature of the request. If a search warrant or other court order is
necessary, OCI will lead or direct this part of the investigation. Report all refusals to the local OCI
field office.

8.1.6 - General Investigative Techniques – What do I do during an

investigation?
[Link] - Interviews
An interview is a one-on-one structured conversation to obtain accurate, reliable information. To
gain the most facts and information, be prepared and conduct the interview methodically with a set
purpose.
[Link].1 - Preparation
Interviews may be conducted in various agreed upon meeting places. Choose a non-threating
place for the interview, such as a conference room or private office free from distractions or
interruptions. Silence your phone to avoid incoming calls. If possible, conduct the interview
away from the person’s normal area of business. If interviewing a consumer at their home, try
to interview them in an area of their home that has the least distractions. If possible, conduct
the interview sitting directly across from the interviewee.
Begin by researching your topic. Set a specific purpose and objectives for what you want to learn
during the interview.
[Link].2 - The Interview
• Set the tone. In most cases, you may tell the interviewee what they can expect. Start
out with generic or easy-to-answer questions to establish a baseline and to put the
subject at ease.

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• Avoid asking leading questions. Ask open-ended questions that encourage the
interviewee to talk and provide a full answer rather than a “yes” or “no” (e.g., Tell me
about…, How did you…, Why was this…, etc.) Avoid combining more than one idea into
the same question. Frame the question to generate an answer one fact at a time. Avoid
questions that are accusatory or that trigger a defensive response. ‘Yes’ and ‘no’
questions may be used at the end of the interview to affirm facts.
• Keep an open mind.
• Do not express your opinions, thoughts, and your own conclusions about the situation
or what the interviewee says. You are trying to learn information and facts from the
interviewee so avoid being too familiar with the topic in your responses. Set aside any
potential biases while conducting the interview.
• Take detailed notes or have another CSO present to take notes. This is extremely helpful
since you are focused on the objectivity of the interview. If taking notes makes the
interviewee uncomfortable or hinders the interview, you may take notes immediately
after the interview and identify the time between the interview and your notetaking
and explain the circumstances for not taking contemporaneous notes during the
interview. Only use quotes (“…”) if you are certain they are exact. It is a good practice to
read a quote back to the interviewee to confirm its accuracy.
• Pay attention to the subject’s verbal and non-verbal communication.
• Ask for clarification and more detail if responses are not clear to you during the
interview. Repeat answers back to the subject to ensure you heard the information
correctly. Ask if documents exist and to support any part of the interviewee’s story.
Collect any available relevant documents.
• Follow-up questions may help establish additional facts. If your questions are avoided or
the answers seem evasive, try rephrasing the question and ask it again. You may also
change topics and return to an issue later.
• Allow the interviewee enough time to answer your questions and avoid interrupting
them. Sometimes silence can be a tool to prompt further explanation or reaction.
Before concluding the interview, ask the subject if there is anything else they would like
to provide or discuss. Ensure that the interviewee has your contact information in case
they recall any more material information later.
• Interviews and discussions with complainants where tampering is suspected or alleged,
should include a discussion of the Federal Anti-Tampering Act (Exhibit 8-1). This
discussion needs to be documented in the investigation report/memo. See IOM [Link]
[Link].3 - Safety
Developing a Situational Safety Plan may also be required.
In preparation for any consumer complaint interviews, you should take your personal
safety into consideration. Refer to IOM [Link] for more information.
[Link].4 - Basic Information to Obtain
Obtain an accurate and complete description of the product, e.g., brand name, product name,
flavor, or variety, how packaged, storage conditions required (i.e., refrigerated or shelf stable)
etc. Refer to Consumer Complaint Procedure (SOP-000544).
It is important to accurately determine the sequence of events leading up to the complaint.

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You cannot rely on consumers responding to follow-up calls or providing additional information
later.
[Link] - Medical Records
In investigating complaints where the complainant was seen by a health professional, contact the
health professional concerning the nature of the alleged illness/injury, and the relationship to the
product. You may occasionally find the complainant has not mentioned the product to the health
professional as a potential cause of the illness or injury. Use judgment as to the usefulness of
collecting medical records. Examples of medical records to collect include Admission History and
Physical; Emergency Room/Clinic Record of the event if patient not admitted; Discharge Summary;
Autopsy Report; and Death Certificate. See also IOM [Link].
If collection of medical records is necessary, use the letter template found in Exhibit 8-2. It may be
necessary to use multiple letters if medical records are at different locations. If you encounter
resistance from the medical professionals in providing records, you may refer them to 45 CFR
164.512(b) which explains the exemptions allowing FDA access to the medical records. Definitions
under the Privacy Act are found in 45 CFR 164.501.
FDA is exempt from the HIPAA Privacy Rule as a public health authority. If a situation arises in which
information sharing is impeded by the belief that FDA lacks authority to receive this information,
you may share the language below during disease outbreak investigations or consumer complaint
follow-up. References are provided for further information.
“The Health Insurance Portability and Accountability Act (HIPAA), Standards for Privacy of
Individually Identifiable Health Information; Final Rule (Privacy Rule) permits disclosure of privacy
information without a written patient authorization for specific public health purposes. Specifically,
the Privacy Rule permits covered entities to disclose this type of information to ‘a public health
authority that is authorized by law to collect or receive such information for the purpose of
preventing or controlling disease, injury, or disability, including…the conduct of…public health
investigations’ 1. Per the Privacy Rule, ‘public health authority means an agency or authority of the
United States…including the employees or agents of such public agency…that is responsible for public
health matters as part of its official mandate’ 2. FDA, as a public health authority responsible for
ensuring the public health and safety with regards to FDA-regulated products, meets this definition.
Our authority to receive information related to FDA-regulated products comes from the Federal
Food, Drug and Cosmetic Act (FD&C Act), the Public Health Service Act, and regulations issued under
those authorities.
“The Privacy Rule permits covered entities to disclose protected health information (including
personal privacy information) directly to the FDA for certain public health activities and purposes,
provided that the disclosure is limited to the minimum amount necessary. During FDA follow-up to
reports of illnesses potentially associated with FDA-regulated products, access to personal privacy
information including names and contact information is necessary in order to ensure timely follow-
up and, potentially, removal of implicated products from commerce. FDA is also responsible for
safeguarding personal privacy information released to us according to the Freedom of Information

1
45 CFR 164.512

2
45 CFR 164.501

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Act and the Privacy Act 3 and our information disclosure regulations 4, and is obligated to comply with
all applicable protections, procedures, and legal requirements against the unauthorized disclosure of
this information.
“Consequently, personal privacy information including case names and contact information should
be shared by state and local health departments with FDA authorities during an investigation of
potentially adulterated FDA-regulated products, including illness outbreaks potentially associated
with FDA-regulated foods. Prompt information sharing speeds the agency’s investigation and can
prevent additional illnesses and/or deaths due to an adulterated FDA-regulated product.”
If the investigation is related to an outbreak/illness and the Office of Emergency Operations or
Coordinated Outbreak Response and Evaluation is coordinating the incident and a medical officer
has been assigned to the investigation it is preferred that the CSO, with supervisory concurrence
communicates with the medical officer about the documents to collect prior to the collection. In the
absence of a medical officer being assigned or available, the CSO in collaboration with the
supervisor, should collect medical records most relevant to the incident. Once collected, the Office
of Emergency Operations or CORE if involved, or the supervisor in consultation with their
management should identify a medical officer to review the records.
The records containing personal identifiable information (PII) and medical information need to be
protected. All medical information sent to the medical officer electronically needs to be encrypted.
Hardcopy records shipped to the medical officer need to include shipment tracking information and
request signature upon receipt. The medical records should be addressed to the attention of the
specific medical officer who will be conducting the review.
Any hard copy medical records in the possession of the CSO after sending to the medical officer or
returned by the medical officer, should be placed in a sealed envelope, identified to contain PII and
medical information and filed with the investigation memo.
When collecting medical records from a Department of Defense (DoD) medical facility, identify
yourself to the commanding officer of the facility or representative and request authorization to
examine and copy records. Please note that DoD Directive 6040.2, Release of Information from
Medical Records authorizing release of medical information to government agencies, has been
rescinded by DoD; if the representative of the facility requests a letter authorizing release, use the
same letter as above.
If the hospital does not accept the FDA letter for Authorization for Medical Records Disclosure,
obtain and complete the one the facility provides.
Collect all medical records pertinent to the investigation. See IOM 5.6.5.
References are available at: [Link]
[Link] - Sample Collection
Chapter 4 covers sample collection methods and authority. In general, collection of samples during
an investigation will be directed by the assignment or in discussion with your supervisor. Opened
containers of product are rarely sampled.

3
5 USC 552 and 5 USC 552a

4
21 CFR Part 20 and 21 CFR Part 21

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Prior to initiating sample collection, you may consider contacting the home division of the
manufacturing plant. They may be aware of an existing issue related to the product and problem.
Samples should be collected immediately, while they are available.
When a consumer portion is collected, intact containers of products of the same lot should be
collected from the retail and wholesale levels if available. When collecting samples at retail or
wholesale, ask if the firm is aware of any other complaints concerning the product. Refer to IOM
[Link] for additional information concerning collection of consumer portions. Maintain the
confidentiality of the complainant. If the distributor inquires about holding or recalling the product,
refer them to your supervisor.
[Link] - Internet Investigations
The internet can provide useful information when conducting many types of investigations,
including obtaining basic background information. Often you can use your government issued
computer or cell phone for basic firm information (e.g., hours of operation, key personnel, location,
directions, etc.). In these cases, you are using the internet as a tool to assist as you determine where
and how to collect information and conduct your investigation.
When conducting specific internet investigations and documenting evidence online, refer to
Introduction to Internet Investigations.
([Link]
Policy/SitePages/[Link])
Note: This website is on the FDA Intranet and not accessible outside of the FDA Network.

8.1.7 - Locations for Investigations – Where do you conduct an investigation?

Some examples of locations for investigations include:
Retail establishments.
A consumer’s residence.
Other government agencies.
Location agreed upon with a complainant.
Hospitals/physicians’ offices.
Online.
Depending on the circumstances involved, an investigation can be performed at almost any location.

8.1.8 - Internal and External Organizations Involved - Who else will I

encounter during an investigation? Why are they involved?
The agency works cooperatively with many outside organizations, primarily other federal government
agencies and state, local, tribal, and territorial (SLTT) authorities. Internally, you may work with
individuals from OII headquarters, OCI, other programmatic divisions or center employees. Some of
these organizations become involved due to contractual obligation, statutory obligation, request for
expertise, or memorandum of understanding (MOU). Chapter 9 of the IOM provides information about
major organizations that FDA interacts with, both federal and state.
[Link] - Interagency Referral
One of FDA's functions is to assist SLTT and other federal agencies in conducting investigations,
collecting samples, and conducting plant inspections. If you find information during the course of an

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investigation that may be relevant to another federal agency, a referral request can be made by
filling out an online form https:/[Link]/scripts/IRF/.
Primary regulatory authority may belong to FDA or another agency. It is important to be aware of
which organization has primary regulatory authority during an investigation.
For Grade A Milk products, raw molluscan shellfish, and retail food operations, within HFP the Office
of integrated Food Safety System Partnerships (OIFSSP) has lead responsibility. For these
cooperative programs, the state has primary authority for investigations. FDA often accompanies
and assists states during investigations through the Office of State Cooperative Programs. If your
investigation involves Grade A Milk or Milk Products, raw molluscan shellfish, or retail food
operations, contact the Office of State Cooperative Programs before investigating.
[Link] - Intra-agency/Cross-Program
Outside of OII, you may be involved other components of FDA. FDA staff work closely with one
another to ensure the safety, efficacy, and security of FDA-regulated products.

8.1.9 - General Investigation Reporting – How and where do I report my

investigation?
Reporting an investigation is almost always done using a memorandum and captured as an operation in
eNSpect for Domestic Investigations (OP13) or Foreign Investigations (OP15) and in SERIO for Import
Investigations (OP24). The time associated with the investigation will be captured in the noted system
(eNSpect or SERIO).
The format of domestic and foreign investigation memos is not as defined in sections as an
establishment inspection report (EIR). As a general guideline you can first summarize why or give the
reason for the investigation, what was covered, and briefly state the findings. After this, you can go into
detail about how you conducted the investigation and what you found. Reporting the course of your
investigation and your findings chronologically works in most situations. For long narratives, using
headings will make it easier for the reader to follow your reporting. Refer to IOM 8.1.9 for further details
on the format for domestic and foreign investigation memos.
Import investigation memos are formatted into sections, as described in IOM [Link]. Refer to IOM 6.6.3
for reporting investigations involving the importation process.
Some types of investigations have forms that need to be completed in addition to the narrative within
the memo. For example, FDA Form 3623, the Farm Investigation Questionnaire (FIQ), must be
completed for all farm investigations.
[Link] – Entering domestic and foreign investigation operations in eNSpect
eNSpect is used to capture information about the assignment, the establishment, and the
investigation. Investigation operations are reported in eNSpect for a Domestic Investigation (OP13)
or Foreign Investigation (OP15). General information on how to complete these operations in
eNSpect field client are provided below. (For complete instructions, refer to the eNSpect Resources
Site for the current eNSpect User Guide and eNSpect training.) The “Investigation” tab in eNSpect
includes the “Details,” “Time & Coverage,” and “Endorsement” pages.
The “Endorsement” page has three sections: Endorsement, Attachments, and Supervisor Feedback.
Attachments, such as the investigation memo, are uploaded to support your findings under the
“Attachments” section of the endorsement page. All three sub-sections must be completed, and

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each has a maximum of 4000 characters per text box. The narrative entered in these sub-sections
will depend on several factors (e.g., program/division, type of investigation, assignment). If the
character limit prevents you from describing all relevant facts, an investigation memo should be
prepared and uploaded under the “Attachments” section. If the space is adequate to report your
investigation, you may not need to prepare a memo. For example, reporting OEI improvement
activities and firms determined to be out of business (OOB) are two situations where a memo
usually is not necessary. However, this can also depend on your program and/or division
procedures. Programs of divisions may require a memo for all investigations. Consult with your
supervisor if you are unsure whether a memo is required for the investigation.
Your supervisor or other designated individual will review and endorse the investigation report
(OP13 or OP15) in eNSpect. An inspection (OP11 and OP12) can be converted to an investigation
(OP15 and OP13, respectively) in eNSpect when you were unable to complete the inspection (often
referred to as a “washout”). Obtain supervisory concurrence before converting an inspection to an
investigation due to a washout. For example, your supervisor may want you to hold onto an
inspection assignment and inspect a seasonal firm later in the year rather than converting the
inspection to an investigation as a washout.
Reasons to convert an inspection to a washout include the following: Out of Business (OOB); Not
Official Establishment Inventory (NOE); Inactive (INA); Seasonal (SEA); Operational but not an FDA
obligation (OPR); Pre-Production (PRE-PROD), and Firm does not meet assignment criteria (OPR).
The information reported in your investigation, especially the reason for the investigation, may be
helpful to future investigators. If the investigation finds further action is recommended, do not
convert the associated inspection assignment to a “washout” in eNSpect. Report the operation
using an ad-hoc eNSpect investigation (OP13 or OP15). Do not return the associated inspection
operation (OP12 or OP11) to FACTS for conversion to an investigation. An example of a further
action would be a request for Import Alert because of an inspection refusal in a foreign country.
[Link].1 - Investigation memo: format, content, endorsement, and routing
Exhibit 8-3 demonstrates the general format of a memorandum of investigation (investigation
memo), which includes the originating division/office; responsible firm; FDA Establishment
Inventory (FEI); to/from; date; and subject. When writing an investigation memo, consider the
following:
• Document all pertinent information (e.g., who, what, when, where, why). At a minimum,
the investigation memo should contain the following information: the reason for the
investigation; background and history, if any; findings; and recommendations.
• Provide details of how you conducted the investigation and describe pertinent data,
references, attachments, etc.
• Headings may be used if it contributes to presenting your report in a clear, logical, and
concise manner.
• Routing for the memorandum should be included. Consult with your supervisor if unsure
of the correct routing information to include.
[Link] - Entering import investigation operations in SERIO
Import investigations are created and recorded as OP24 in SERIO. Import investigation memos are
written and reviewed in SERIO and used to capture assignment information, firms involved, and the

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investigation. The information reported in your investigation may be helpful to future investigators.
For instructions on recording an OP24 in SERIO, refer to the SERIO User Manual.
[Link].1 - Import investigation memo: format, content, and endorsement
Exhibit 8-3-1 demonstrates the format and content of an import investigation memo, resulting
from import investigation work conducted under IOM 6.6 – Import Investigations. Exhibit 8-3-1
includes the general format from Exhibit 8-3 and organizes the content of the memo into five
sections (Assignment, Relevant History, Investigation, Closing, and Endorsement). The following
information should be captured for each of the five sections of an import investigation memo:
• Assignment:
o Introduce the initial assignment, including its scope, that led to the investigation.
o Include how you became involved, the date (include time of day if relevant) you
became involved, and the location of investigation (name, address, city, state, zip).
• Relevant History:
o Provide a brief history of the firm, including any previous investigations or
inspections and noting the resulting classifications.
o Describe any action taken by the division and describe any corrective action taken
by the firm.
• Investigation:
o Provide a chronological narrative of the events of the investigation in its entirety.
o Identify the person(s) involved, including responsibilities, roles, and titles.
o Describe in detail the relevance of all attachments and exhibits collected during the
investigation (For example, affidavits and entry documents).
o Include the appropriate information for the identified violation pattern(s), as
identified in IOM 6.6.4.
• Closing:
o Restate and resolve the assignment.
o Include refusals, voluntary corrections, and promises made by the firm.
o List Attachments.
Note: The name of an attachment file that is uploaded from your computer will be
the actual document name displayed in this section of the memo. (e.g. “Form FDA
463a”, “Email communication to Firm”)
o List Exhibits.
Note: The name of an exhibit file that is uploaded from your computer will be the
actual document name displayed in this section of the memo. (e.g. “Invoice
78901”, “Receiving Record”, “Photograph of product”)
• Endorsement:
o Include the reason for the investigation (e.g. workplan, specific assignment, etc.)
o Restate the subject of the assignment.
o Provide a brief history of previous investigation findings and subsequent compliance
or CBP actions, if applicable.
o Provide a concise summary and evaluation of the current investigation.
o Include refusals, voluntary corrections, or promises made by the firm’s
management.

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o Recommend regulatory and/or further investigational action consistent with

investigational findings and agency policy.
Endorsements are completed by the supervisor; however, the supervisor might request the
investigator to draft the endorsement.
NOTE: For more detailed instruction on what specific information to obtain during the
investigation for inclusion in the memo, refer to the specific violation patterns in IOM [Link]
through IOM [Link].

[Link] - Reporting complaints/follow-ups

Refer to SOP-000544, Consumer Complaint Procedure, in the Quality Management Information
System (QMiS) for detailed instructions on intake, tirage, escalation, dispositioning, and follow-up of
consumer complaints of FDA-regulated products received by and/or submitted to OII personnel.
If you conduct an inspection to follow-up on a complaint, any findings related to the complaint
should be documented in the Establishment Inspection Report or in one of the following ways for an
OP13/OP15, if not involving confidential sources, whistleblowers, etc.,
If you conduct an inspection as above, but it involves a confidential source or whistleblower, follow
directions for reporting provided in Consumer Complaint section related to Confidential Sources or
Whistleblower.
Information contained in the investigation memo or sub-sections of the “Endorsement” section of
eNSpect, should at a minimum include a general discussion of the complaints that were covered and
the complaint number(s). The complaint numbers should be recorded in the endorsement of the
OP13/OP15. All FDA complaints requiring coverage during an inspection or investigation will
populate in the eNSpect assignment based on the FEI. The consumer complaints tab in eNSpect
must be completed for complaint coverage and suggested follow-up disposition when FDA
complaints are listed.
Investigations (OP13 or OP15) covering complaints must only contain one FEI and have the
investigation basis of consumer complaint.
The time spent on the consumer complaint follow-up should be reported in the eNSpect assignment
(OP13 or OP15) under the appropriate complaint Program/Assignment Code (PAC) for any
complaints covered during the investigation. Refer to the PAC Master List for the appropriate PAC.
If a sample is collected during a domestic consumer complaint follow-up investigation, the sample
number is linked to the OP13 in eNSpect by entering the sample number under the “Details” page in
eNSpect. In addition, an OP31 (Sample Collection) with a collection report containing all relevant
information will be completed. If the primary response to the complaint is collection of a sample
and no further investigation, no assignment (OP13 or Op12) is generally created for completion in
eNSpect. In this case all relevant documents would be included with the OP31 collection report.
[Link] - Reporting information obtained from a confidential source
During an investigation, inspection, or other operation, you may acquire information from a
confidential source. See IOM 5.4 for information on how to interview confidential source and
document information obtained from them. Information received from a confidential source during
an investigation should be captured in an investigation memo as an attachment to the OP13/OP15.

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See IOM 5.4 for suggestions on how to protect the identity of the confidential source when writing
your investigation memo. Information contained within an OP13/OP15 is outside the scope of FMD-
145 (Release of the Establishment Inspection Report (EIR) and should be reviewed by FOIA
personnel for appropriate action before release.
If during an inspection you interview a confidential source or whistleblower, do not include any
identifiable information in the EIR and prepare a separate memo of investigation to cover this part
of the inspection. Enter as an OP 13 or OP 15. See IOM 5.4.
[Link] - Reporting investigations conducted during disaster response
There is no prescribed format for narrative reporting of disaster operations. Consult with your
supervisor as to your division's preference. If operations were conducted as an investigation, you
will likely write an investigation memo to document the activities. The memo should briefly describe
the onset of the disaster, its magnitude, and your activities. Include cooperation with officials,
planning operations, and the logical sequence of your activities.
Your memo must contain exhibits consisting of photographs, diagrams, records, references to
samples, and any other items necessary for proper presentation of the operation. Refer to RPM
Chapter 8 “Emergency Procedures,” for guidance on reporting natural disasters and civil disorders.
List amounts of materials or products destroyed and the method of destruction. Prepare charts and
lists as necessary to provide documentation of all affected lots destroyed, reconditioned, or
released. Include kinds and amounts of materials segregated, released, reconditioned, and
destroyed and method of reconditioning and/or destruction.
In situations where an ICS structure has been implemented, operations are reported through the
IMT and use of ICS forms, situation reports, after-action reports, or other documents as appropriate
to the operation. The IMT will direct you on reporting your time spent working on the operation.
If a sample of an FDA-regulated product is collected as part of the disaster response under ICS, an
OP31 (Sample Collection) with a collection report containing all relevant information will usually be
completed. In this case, your time spent conducting the sample collection would be reported in
FACTS as part of the OP31 and using the PAC appropriate for the assignment.

8.2 - Human and Animal Food Investigations

8.2.1 - Coordination
The initial step in coordination of a human and animal food investigation is notification of the potential
incident. Notification to FDA may be received from SLTT officials via the district ERC or divisional staff;
consumer complaints or adverse event reporting portals; or from federal entities such as the Centers for
Disease Control and Prevention (CDC) alerting the FDA of illness clusters. Regardless of the source, once
a potential incident is identified, the ERC (DERC) is the primary point of contact (POC) for coordination of
the response at the field level. (See Communications SOP for ERCs)
If agency-level central coordination is needed, CORE or CVM will most often provide management of the
incident based on whether human or animal foods are suspected. However, there are instances when
food incidents may be coordinated by OEM or a HFP office based on the specific commodity and scope
of incident. (See Exhibit 8-4 for the “Table Depicting Incident Coordination Body by Type of Incident.)

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8.2.2 - Foodborne Illness Outbreak Investigations

[Link] - Cooperation with Other Agencies
One of FDA's functions is to assist SLTT and other federal agencies in conducting investigations,
collecting samples, and conducting firm inspections if warranted.
In addition to state and local health departments, the following federal agencies may also become
involved in investigating foodborne disease outbreaks:
• Centers for Disease Control and Prevention (CDC)
• U.S. Department of Agriculture (USDA)
• Environmental Protection Agency (EPA)
CDC becomes involved in foodborne outbreaks when people in more than one state are sick with
the same germ from contaminated food. Their role involves coordinating the epidemiologic
investigation, including identifying illnesses. CDC works directly with CORE to provide
epidemiological information to help identify a possible food vehicle and focus the scope of FDA’s
investigation. During an outbreak, CORE and CDC coordinate with internal and external partners
(including international governments) to help determine the outbreak source and prevent future
illness.
USDA is responsible for investigating outbreaks involving meat and poultry products under their
jurisdiction. Whenever a complaint is received involving any meat-containing product, including
such items as soups, combination infant foods, frozen dinners, etc., evaluate the need to contact
USDA. Most products containing red meat or poultry are regulated by USDA. The exceptions include:
• products containing meat from game animals, such as venison, rabbits, etc.
• meat-flavored instant noodles
• "pork and beans" (which contains only a small amount of pork fat and is regulated by FDA)
• Closed face sandwiches
USDA-regulated products display on their labels a round "shield" with the USDA Establishment
Number. Alternatively, the establishment number may be identified in the lot number. Red meat
products under USDA jurisdiction will often contain the abbreviation "EST" followed by a one to
four-digit number; poultry products under USDA jurisdiction will contain the letter "P" followed by a
number.
IOM 9.2.1 and [Link] provide information for reporting suspected outbreaks to USDA and CDC. In
addition, FDA and CDC have an agreement that FDA will be immediately advised whenever CDC
ships botulism antitoxin anywhere in the United States or its possessions.
Whenever a water source is suspected as a likely origin of the agent of an illness outbreak, the EPA
should be notified. For example, when investigating a foodborne outbreak on a vessel passenger
conveyance, you may find the water used in food preparation to be from a land-based source or
from an on-board water treatment plant. Both of these sources would fall under EPA jurisdiction.
See IOM 9.2.12.
When two or more people get the same illness from the same contaminated food or drink, the
event is called a foodborne illness outbreak. For more information related to foodborne illnesses,
please refer to [Link]
illness.

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[Link] - Outbreaks on Foreign Flag Vessels

If a suspect outbreak involving a foreign flag vessel or a U.S. flag vessel with an international
itinerary comes to your attention, report it to your supervisor and the district ERC immediately. The
district ERC will provide the information to OEM/OEO. The CDC assumes primary jurisdiction for
foreign flag (non-U.S. registry) and U.S. flag vessels with international itineraries entering the U.S.
and traveling in U.S. waters. See IOM [Link].
[Link] - Outbreaks Involving Interstate Conveyances
Reports of illness attributed to travel on an interstate conveyance (plane, bus, train, or vessel) are a
shared responsibility of FDA, CDC, USDA, EPA, and potentially others. When a report of illness is
received, notify the ERC in your division/district. The ERC will contact the CORE Signals Team at
CORESignalsTeam@[Link]. Please include the HFP Office of Food Safety Interstate Travel on
any email correspondence ([Link]@[Link]). In addition, you are encouraged to share
the report with state and local public health officials. The following activities are to be coordinated
with local/state public health officials: Interviews with the ill passenger(s), family members (well and
ill), caregivers, and/or health professional (as appropriate) should be sufficiently probative to
hypothesize if the food, water, or an environmental transmission is related to the illness.
Transmission of illnesses, particularly viral diseases, by ill employees and contaminated
environmental surfaces can result in illness carryover between successive trips and should be
considered. Factors such as symptoms, time of onset of symptoms, food history for the 72 hours
prior to onset of the first symptom, any clinical laboratory results, and other potential exposures
should be documented. The carrier should also be contacted to determine if other reports of illness
have been received (passengers and employees). Obtain any illness logs from the carrier. The
information developed should be evaluated to determine if further follow-up is necessary. On those
carriers where a reservation system is used, obtain the names and phone numbers of passengers,
and a passenger manifest, if available. If a reservation system is used, then a passenger manifest
should also be available. A manifest will provide passenger seating, which will help identify
additional cases based on proximity or in the event of an etiological agent like Norovirus, the
passengers who occupy the seat on the next flight could also be at risk of infection. It may be
necessary for the state/local health authorities, CDC or FDA to contact other passengers to
determine if they became ill.
If additional cases are uncovered during these contacts, immediately notify the appropriate ERC in
your division who will then contact the CORE Signals Team at CORESignalsTeam@[Link], HFP
Office of Food Safety Interstate Travel, and the state and local public health authorities in all of the
affected states. FDA will work cooperatively with these authorities and request their assistance in
conducting an epidemiological investigation and collecting patient specimens. Note: If at any time
the local/state public health officials are unable to assist with an investigation, have the district ERC
notify CORE Signals Team at CORESignalsTeam@[Link] who will contact the CDC and request
assistance with the epidemiological investigation.
[Link] - Outbreak Management
CORE coordinates FDA’s efforts to prevent, detect, investigate, respond to, evaluate, and apply
lessons learned from foodborne outbreaks and public health incidents. Along with OII, HFP subject
matter experts (SME), and others in FDA, CORE manages the strategy and implementation of
outbreak response activities and evaluates environmental, epidemiologic, and laboratory data to

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inform assignments and direction of outbreak investigations related to foods, cosmetics, and dietary
supplements. OII’s primary role in the outbreak investigation is to perform activities related to
tracing food from source to destination; food and environmental sample collection and analysis; and
facility investigations.
If you become aware of a foodborne outbreak, contact the appropriate district ERC immediately
who will then contact the CORE Signals Team at CORESignalsTeam@[Link].
[Link] - Conducting Foodborne Illness Follow-up
A priority for all foodborne illness investigations is to establish the basis for implementing control
measures to stop transmission and prevent additional illnesses.
CDC is the federal agency with primary responsibility for investigating large, multi-state foodborne
illness outbreaks. FDA plays a role in outbreak response generally by collecting samples, obtaining
traceback information, and conducting food establishment inspections. CDC guidance for
investigating foodborne illness is available at Investigating Outbreaks. SLTT generally conducts
small, local foodborne illness outbreaks using generally the same process. In FDA, CORE guides
investigations into the cause of foodborne illness outbreaks after notification from CDC that an
outbreak is ongoing.
A resource for conducting epidemiological investigations is the Council to Improve Foodborne
Outbreak Response (CIPHOR). Its website ([Link] has many resources available to aid
during an epidemiological investigation.
If you receive a report of a foodborne illness or an outbreak provide details to your district ERC and
determine the extent of investigation you need to conduct. If you are required to respond to a
foodborne illness outbreak, use the following as guidance.
[Link].1 - Preparation
Divisions should maintain enough supplies of equipment used for sampling during a foodborne
illness investigation. Assure all sterile supplies are within expiry. It is important that swabbing
materials be monitored and utilized in a first in, first out manner to prevent the expiry of
supplies.
[Link].2 - Interviews
Reports of foodborne illness can come from many sources, such as:
• Laboratories
• Hospital-based laboratories
• Clinical laboratories
• National or regional commercial referral laboratories
• Local or state health department laboratories
• CDC laboratories
• Health care institutions
• Hospitals (e.g., hospitalized patients reported by infection control practitioners)
• Emergency departments
• Long-term–care facilities or nursing homes
• Physicians
• Schools and childcare centers
• Food establishments (e.g., restaurants)

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• State health departments

Regardless of the source of the report, the diagnosis must be verified by a thorough case history
and, if possible, by examination of appropriate food samples and clinical specimens.
[Link].2.1 - Conducting Interviews
Normally, conducting foodborne illness interviews is not a role CSOs will perform since food
history/symptoms are typically gathered by CDC and/or SLTT partners. Follow the guidelines
upon contacting the affected person in the General Interview section (IOM [Link]) of this
chapter and the following:
• Identify yourself and explain the purpose of the visit or call.
• Ensure confidentiality.
• Conduct interviews in a private location.
• Be non-judgmental.
• Show empathy and attempt to build rapport with the interviewee.
• Exhibit genuine concern for persons affected and be sincere and respectful when
requesting personal and confidential information.
• Set your level of communication based on the person being interviewed.
• Be tactful. People are sometimes sensitive to questions about age, sex, special
dietary habits, ethnic group, excreta disposal, and housing conditions. Phrase
questions thoughtfully.
• While keeping the interview as conversational and as natural as possible,
communicate a sense of urgency and emphasize the positive contribution already
made by the interviewee toward the control and prevention of foodborne illness.
• Use open-ended questions.
• Phrase your questions so the interviewee(s) will describe their illness and the foods
and events which they feel are associated.
• Accurately record what interviewees say.
• Gently redirect, as needed.
• Probe if answers are vague, particularly about time of symptom onset.
• Asking references may help their memory, for example, “What did you do prior to
eating lunch?”
• Work with epidemiology staff to provide language interpretation, if needed.
• Thank interviewee at closing and explain how the information will be used.
[Link].2.2 - Information to Gather
Targeted, effective and pertinent information gathering is critical in a foodborne illness
outbreak investigation. Per the CDC: Health officials use three types of data to generate
hypotheses about the likely source of an outbreak: epidemiologic, traceback, and food and
environmental testing. Investigators begin by trying to pinpoint how the pathogen spread.
They review details such as:
• The specific pathogen causing illness.
• Where sick people live.
• How old they are, their sex, and race/ethnicity?
• Did they have contact with a sick person?

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When a contaminated food is suspected, investigators must consider many different foods
that may be causing the illness. Interviews help to establish a list of foods people ate before
getting sick and collect information on other exposures such as restaurants where the ill
person ate and stores where they bought food. This list is used to help investigators
determine what food or ingredients the sick individuals may have in common.
Consult with management, ERCs, HFP SMEs, state liaisons, state partners, FDA, CORE, and
others involved in the outbreak, as necessary, to determine what information is needed
from the interviewee(s). Interview topics can include:
• Interviewee information
• Clinical information
• A standard list of food items
• Each meal a person ate before becoming ill and all meals and snacks eaten seventy-
two hours before onset of illness. The food, even the meal, which precipitated the
illness, might not be obvious and the type of illness will sometimes provide clues:
o If the first and predominant symptoms are nausea and vomiting, concentrate
questions on foods eaten recently.
o If the first and predominant symptoms are diarrhea and abdominal cramps,
foods eaten six to twenty hours before onset of illness are suspect.
o If diarrhea, chills, and fever predominate, foods eaten twelve to seventy-two
hours before onset of illness are suspect.
o More unusual illnesses often present different clinical patterns. For instance,
some illnesses such as Typhoid Fever and Hepatitis A, have incubation periods
greater than 72 hours.
• Food allergies, special diets, vitamins, and supplements
• Sources of food at home/outside of the home
• Animal contact and pets
• Specific food categories
• Food shopping habits
• Travel
• Restaurant dining
• Attendance at events where food was served
Although some may not have been ill, use this detailed interview approach with each
individual identified in the initial complaint or alert, until there is sufficient information to
determine the scope and source of the foodborne illness outbreak.
[Link].3 - Medical Records
Physicians' and hospitals' records can be useful in verifying reported signs, symptoms and other
clinical data and can sometimes rule out the possibility of foodborne illness. See General Section
on Medical Records (IOM [Link]).
[Link].4 - Sampling Procedures
CAUTION: Never taste any of the food products. Handle all samples with caution to
prevent accidental exposure to and/or ingestion of even minute amounts of the
contaminated or suspect product.

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[Link].4.1 - Sample Collection

During investigations of foodborne illnesses, cooperate with other public health officials in
collecting samples of items that may be associated with the outbreak.
Use interview information and a menu or data from an attack-rate table to determine which
of the foods from the implicated meal are most suspect and collect samples of the suspect
foods. Check storage areas for items that may have been overlooked. Check garbage for
discarded foods or containers. Suspect foods often are discarded by an operator if he thinks
someone may have become ill as a result of eating in his establishment. Because one of the
primary tasks of the investigator is to prevent further illness, take appropriate action to
prevent distribution or serving of any suspect food. If no foods remain from the suspect
meal or lot, try to collect samples of items prepared in a similar manner, but subsequently
to the suspect lot. Collect ingredients or raw items used in the suspect food. Determine
supplier, distribution, and code information on ingredients and packaged foods to aid any
investigation of the same lot in distribution channels.
Collect samples aseptically. If foods are to be examined for organophosphate pesticides or
heavy metals, do not use plastic containers. Use glass jars with foil-lined lids because
substances from the plastic can leach into the food and interfere with analysis.
The following are examples of articles normally collected:
• Remaining portions of all suspect foods.
• Parent stocks of suspect foods.
• Insecticides, rodenticides, or other poisons which may be involved.
• Suspect food containers such as cans, bottles, etc.
• Utensils or materials used in the preparation and storage of the suspect food.
• Table scrapings and food residues from equipment such as slicing machines, cutting
boards, etc.
NOTE: Clinical specimens such as vomitus, stools, swabs of nasal and throat passages, or
open sores or lesions of food workers are collected by local, state, or CDC health officials or
private physicians. Do not collect these samples.
[Link].4.2 - Sample Size
In general, follow the IOM SAMPLE SCHEDULE in Charts 1, 2, and 3 (IOM Chapter 4). Where
only small amounts of items remain, such as partial meals/leftovers, empty containers with
adhering particles, etc., collect all or as much as possible by scraping from utensils,
equipment, or containers. It may also be necessary to collect the empty containers.
[Link].4.3 - Sample Handling
Record the temperature of the room, refrigerator, or warmer in which the food was stored,
and the temperature of the food that remains after a sample is collected.
Inform the laboratory of the type and number of samples. Discuss methods to preserve and
transport samples, time of arrival, and the person who will receive the shipment.
Follow guidance in Chapter 4 for collecting, handling, and shipping samples. See IOM 4.7.
If the suspect food is a commercial product, examine the original package or container for
coding information to identify the place and time of processing. Your division may notify all
agencies responsible for regulating the products alleged or suspected to have caused the

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illness. Collect additional packages bearing the same code number for analyses for
microorganisms, toxins, seam defects, vacuum, leaks, or other conditions. Be as specific as
possible in requesting the type of analysis.
[Link].5 - Establishment Investigation
After a foodborne illness outbreak is reported and an investigation is initiated, the initial impact
of the incident can create confusion at the facility and could result in conflicting information if
too many entities become involved.
The responsibility for investigating foodborne illness outbreaks rests on a core team of people
who each contribute different knowledge and skills. For FDA-initiated investigations/inspections,
one FDA investigator should be designated as the inspection team leader. The team leader will
set and enforce priorities, coordinate all activities associated with the investigation, serve as the
point of contact about the investigation, communicate with other organizations involved in the
investigation and communicate the recommended course of action determined by team to OII
management. A supervisor and/or ERC should be the coordinator for overall division activities
and the division contact for headquarters personnel. All communications from FDA field or other
offices to the firm's management should be channeled through the supervisor/ERC. The lead
investigator should be responsible for all phases of the physical inspection of the facilities and
briefing the supervisor about team progress.
Upon arrival at the establishment where the suspect food was processed or prepared, identify
yourself to the person in charge and state the purpose of your visit. Emphasize the purpose of
the investigation is to determine what contributed to the outbreak, so preventive measures can
be taken. Attempt to create a spirit of cooperation. Consider the position, feelings, and concerns
of the manager and facility staff; defensive reactions are common.
Many factors could have contributed to contamination before foods came under the control of
the manager. Assure the manager that these possibilities will be investigated. Inform the
manager of the activities proposed and benefits gained for educating their workers.
When investigating the root cause of the contamination obtain the following documents:
inspection reports (state and/or federal), detailed epidemiological data and traceback
investigation reports to try to pinpoint locations of interest, environmental monitoring records,
verification records of the identity, safety, strength, purity, efficacy, and accuracy of raw
materials and packing materials used, and any analysis of resource availability, (e.g.,
documenting sufficient manpower and prescribed raw materials, packaging materials utilized,
substitutions made, etc.), and historical data on weather events, e.g., flooding, for foods
produced in the open outdoor environment.
Perform the following activities:
• Conduct personnel interviews to determine their qualifications, knowledge, experience,
and training.
• Review related logbooks, records, processes, laboratory data.
• Document observations made with photos and videos whenever possible.
• Visit the facilities or farms, where causes of the event occurred (where possible).
• Describe the processes, equipment, and facilities.
• Evaluate the following: the suitability of equipment, facilities, and utility systems; the
calibration and preventative maintenance of the equipment and instruments used; the

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adequacy and the implementation of the relevant standard operating procedures (SOP)
utilized by the food business operator; and the Good Manufacturing Practices (GMPs),
preventive controls and food safety standards, as applicable, utilized in the area where
the product concerned was produced, processed, packed and/or held.
Include all relevant information in the investigation memo or EIR as appropriate.
Review of distribution records and examination of warehouse stock are two important aspects
of a foodborne illness follow-up inspection. Field examination should include an inventory by
code of all stock on hand. When conducting field examinations, follow instructions in IOM
Sample Schedule Chart 2 in IOM Chapter 4.
[Link].5.1- Food Handlers Interviews
If a food is already suspect, interview separately all persons who were directly involved in
processing, preparing, or storing of the food and others who could have observed
preparation and storage. Ask questions in a sequence that discloses the flow of food from
the time it was received until it was served or distributed. Especially inquire about foods
that were prepared several hours or days before being served with the suspect meal and
about foods that have specific temperature requirements. Ask similar questions, suitably
modified, of the managers or workers who were involved in producing, transporting,
processing, preparing, or storing food at other levels of the food chain, as well as individuals
who prepared the food at home.
Food workers who fear criticism or punitive action because of their possible role in the
outbreak do not always accurately describe the food handling as it actually happened. Their
descriptions should be plausible, account for possible sources of contamination, and
indicate possibilities of survival and potential for growth of pathogens. If the description
does not contain all the information desired, rephrase the questions and continue the
inquiry. Seek confirmation of one person's story by talking to others who have knowledge of
the food operation, or by watching the food preparation or processing practices. Be alert for
inconsistencies among the accounts, as told by different individuals.
[Link].6 - Possible Contamination Source
It is important to understand the pathogen and the factors that contribute to the contamination
that resulted in the foodborne illness. Some pathogens, such as Norovirus, are associated with
human fecal contamination, while other pathogens, may be more commonly associated with a
particular food source (e.g., raw meat and E. coli O157:H7).
CDC has identified the most common causes of foodborne illness:
• Food from unsafe source.
• Poor personal hygiene.
• Improper food holding temperatures.
• Improper cooking temperatures.
• Contaminated equipment of cross-contamination of raw with ready-to-eat foods.
You may want to familiarize yourself with Factors that Contribute to Outbreaks of Foodborne
Illness ([Link] ) before
beginning a foodborne illness investigation.

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Exhibit 8-5 ([Link] provides

details about possible food associations with different illness symptoms, latency and factors that
contribute to outbreaks. Although the table lists possible clinical specimens to collect, you
should not collect clinical samples. A SLTT health department may be able to assist and collect
those samples for analysis at a state laboratory.
[Link].7 – Conducting Traceback Investigations
Traceback investigations are important epidemiological tools that are used to determine the
source of food implicated in foodborne outbreaks. Traceback investigations may prevent further
sale and distribution of contaminated food. Commonly, SLTT agencies conduct the initial
epidemiological investigation of foodborne outbreaks and identify suspect product(s) requiring
tracebacks.
CORE issues traceback assignments to the appropriate division(s) and coordinate inter-division
assignments for traceback investigations. The assignment will generally provide all the guidance
needed to conduct the traceback investigation.
Other resources available include:
• the FDA Guide to Traceback of Fresh Fruits and Vegetables Implicated in Foodborne
Outbreaks, dated April, 2001
• the Office of Training Education and Development (OTED) training: ER220: Traceback
Investigations.
[Link] - Reporting
[Link].1 - Reporting Epidemiological Investigations
Follow the reporting guidance in this chapter to report epidemiological investigations. Promptly
submit a complete narrative of the investigation, including references to exhibits, samples,
medical records, and laboratory reports. There is no prescribed reporting format, but it should
be in a logical order. With the inclusion of investigative memos in eNSpect EIR, eNSpect can be
utilized to prepare these memos. See the eNSpect EIR Quick Reference Guide for detailed
information.
Submit copies of any written reports and documents for all injury or illness complaints involving
all HFP products using encrypted email, secure fax transmission, or mailing.
If using mail, use this address:
Food and Drug Administration
HFP/OSAS
CAERS Staff (HFS-700)
5001 Campus Drive
College Park, MD 20740
Attn: CAERS Monitor
Illness/injury complaints involving special nutritional products (See IOM [Link]) must be
accompanied by a CMS Complaint with Adverse Event Section completed when forwarded to
HFP.
If additional follow-up on any complaint involving a HFP product is necessary, the Office of Field
Operations &Response will issue an assignment.

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[Link].2 - Reporting Food Adverse Events

Prompt reporting is essential. You may save the lives of others with prompt reporting. If
consumers contact you to report adverse events including injury, illness, or death related to a
human or animal food, dietary supplement, or cosmetic, they should be directed to report
through the following online reporting systems. If they do not want to report through those
systems, you may report for them.
[Link].2.1 - Food and Cosmetics
Details on reporting adverse events related to human food can be found at the CFSAN
Adverse Event Reporting System (CAERS) website ([Link]
enforcement-food/cfsan-adverse-event-reporting-system-caers).
[Link].2.2 - Dietary Supplements
Details on reporting adverse events related to dietary supplements can be found at the How
to Report a Problem with Dietary Supplements website ([Link]
supplements/how-report-problem-dietary-supplements).
[Link].2.3 - Cosmetics
Details on reporting adverse events can be found at the How to Report a Cosmetic Related
Complaint website ([Link]
enforcement/how-report-cosmetic-related-complaint).
[Link].2.4 - Veterinary Products
Details on reporting adverse events and complaints for animal food and animal medical
products can be found at the CVM Report a Problem website ([Link]
veterinary/safety-health/report-problem).
[Link].2.5 - Reports of Criminal Activity
If a consumer calls to report criminal activity, they should be directed to the Report
Suspected Criminal Activity website
([Link]

8.2.3 - Injury, Illness, Death

Injury, illness, product defect, and adverse reaction complaints should receive a prompt, courteous
response, and assurance their complaints will receive appropriate consideration. Complaint Escalation
must be done when there is an indication of a life threatening injury or adverse reaction, per SOP-
000544.
When you are investigating injuries or adverse reactions, do not make comments or enter discussions
with firms as to the involvement of particular products, unless specifically instructed to do so. Many
adverse reactions come to FDA from consumers or health care professionals through the voluntary
reporting branch of the MedWatch system. Complainant name, address, and contact information
should always be kept confidential, unless express permission is given by the complainant to share it.
Whenever the press has been informed about a complaint, follow instructions found in IOM 1.7. When
the responsible firm invites the news media to observe the inspectional process, follow instructions
found in IOM [Link].
NOTE: Adverse Events Reporting System (CAERS) Staff, HFS-845, 240-402-2405, Fax: 301-436-2452, or
email CAERS@[Link], can assist with questions pertaining to field follow-up related to foods,

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seafood, food additives, dietary supplements, infant formulas, and medical foods. CAERS personnel can
assist in obtaining guidance from HFP's experts.
[Link] - Procedures
When investigating all injuries and adverse reactions the consumer complaint coordinator will
follow SOP-00045 Consumer Complaint Procedure.
Once it is determined by program management that follow-up is deemed necessary, an assignment
will be created and assigned to a CSO, who will then fill out the Follow-up Consumer Compliant
Report in FACTS.
The following should be addressed and confirmed during a follow up investigation with the
complainant.
• Details on the product involved, including brand name, product labeling, and any codes
including lot, expiry, and/or use by codes.
• The source of the product. Where did the consumer obtain it?
• Details of how the product was used, including frequency, in what amounts, any known
previous adverse reactions or pre-existing allergies and whether anyone else used the
product in the household.
• If appropriate, determine if label directions were followed.
• Copies of all labeling/inserts.
• Any research the complainant may have conducted or relied upon and collect copies or
internet web addresses.
• Complete description of the incident (sequence of events) and the nature of the injury or
adverse reaction, including date, time, location, and symptoms or description of injury.
o Any hospital or physician's records available and identify pre-existing conditions which
may have a bearing on the injury or adverse reaction.
o Photographs of the victim's injuries, if significant. See section on Medical Records.
• List names of other persons involved, such as beauty salon operators, medical personnel,
lawyers, insurance agents. Obtain their views on the injury or adverse reaction. The views of
an attending physician are important because they may vary markedly from those of the
patient.
• Determine if the consumer reported the adverse reaction to the manufacturer and the
manufacturer's response.
• Any other consumer complaints, injuries or alleged adverse reactions reported to the
manufacturer concerning the product.
• If necessary, obtain distribution information of the implicated lot(s) from the manufacturer.
[Link] - Specific Product Reporting (Food, Dietary Supplement, and Cosmetic –
Injury or Reaction)
[Link].1 - Dietary Supplements
It is extremely important that FDA conducts appropriate investigations and follow-up on adverse
events attributed to dietary supplement products. DSHEA removed dietary supplement and
ingredients from food additive regulations and therefore it is the agency’s burden to prove them
unsafe. An important source of information concerning potentially unsafe dietary supplements
and ingredients is consumer complaints.

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Injuries or other adverse reactions may be associated with the use of products which:
• Vary from the declared potency or concentration.
• Contain deleterious substances accidentally included in manufacturing.
• Have changed composition or become contaminated after shipment.
• Are mislabeled as to identity warnings or instructions for use.
• Have not been used according to label instructions or the directions of the manufacturer
or prescriber.
• Are dangerous when used according to directions.
When investigating adverse events attributed to dietary supplements, direct attention to, and
document:
• Details on the product involved, including lot codes and expiration dates.
• Source of the supplement. Where did the consumer obtain it?
• Details on the consumer’s use of the product including frequency, dose used,
concomitant treatments, and whether administered by the user or someone else.
• Details on the directions of use provided with the product or otherwise (on the web or
from a practitioner). Obtain copies of labeling and any additional information
concerning use of the product by the consumer.
• Nature of the injury. Include any hospital or physician's records available and identify
pre-existing conditions which may have a bearing on the injury. Obtain photographs of
the victim's injuries, if significant. See IOM [Link] for the procedures used to obtain
medical records.
• Names of other persons involved, such as medical personnel, lawyers, insurance agents,
etc. Obtain their views on the injury. The views of the attending physician are important
because they may vary markedly from those of the patient.
• Complete description of the incident (sequence of events) and the nature of the injury
or adverse reaction, including date, time, location and symptoms or description of
injury.
• Any hospital or physician's records available and identify pre-existing conditions which
may have a bearing on the injury or adverse reaction.
Photographs of the victim's injuries, if significant. See section on Medical Records
[Link].2 - Cosmetics
For clarification of the distinction between cosmetics and drugs, refer to the document, “Is it a
cosmetic, a drug or both? (or is it soap?)” located at [Link]
laws-regulations/it-cosmetic-drug-or-both-or-it-soap.
If you are unsure about a products status, you may contact the Office of Cosmetics and Colors at
(240) 402-1130.
[Link].2.1 - Causes
Injuries or adverse reactions may arise from cosmetics which:
• Are inherently dangerous or which may prove harmful or injurious to a consumer.
• Cause primary irritation of skin, eye, or mucous membranes (including the lungs and
urinary tract) or which may be due to an individual sensitization reaction or allergic
response, or due to ingestion.

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• Have undergone formulation changes or been chemically or microbiologically

contaminated while in the possession of the manufacturer, dealer, distributor, or
end user.
• Are misbranded because they contain unlisted ingredients, lack instructions for safe
use for certain high-risk products (e.g., depilatories, hair dyes), or lack any required
warning statements.
• Have been misused.
[Link].3 - Investigation Requirements for Serious Adverse Events of HFP Regulated
Products
If the suspect product is a cosmetic, interview the injured person and/or the reporter of the
event and complete the FACTS Consumer Complaint Cosmetic Report. If the suspect product is
not a cosmetic, interview the injured person and/or the reporter of the event and complete the
FACTS Adverse Event Questionnaire.
If the suspect product is an infant formula or baby food, immediately inform OEM/OEO at 866-
300-4374 or [Link]@[Link] and investigate on a high-priority basis due to
the continued sensitivity to these incidents. This will include follow-up with the doctor or
hospital, sample collection, and analysis of appropriate product. Refer complaints involving baby
food regulated by USDA for appropriate follow-up. See IOM [Link] and 9.2.1.
Obtain Medical Records as described in IOM [Link].
If the adverse event is a death, the following medical records should be considered for
collection:
• Admission history and physical or emergency room/clinic record of the event if the
patient was not admitted
• Discharge Summary
• Autopsy Report
• Death Certificate
If you believe a suspect product should be sampled, discuss with your supervisor.
For all events, a memo of investigation will be completed. Send a complete copy, including
copies of all labels and labeling, Medical Records Letter (IOM Exhibit 8-2) and medical records
collected to the CAERS Staff.
[Link].4- Undeclared Allergen/Allergic Reactions
Suspected undeclared allergen complaints should receive high priority. Undeclared allergens in
food products often result in recalls.
The following should be addressed and confirmed during a follow-up investigation with the
complainant:
• List all the complainant’s food allergies.
• List all foods consumed within approximately an hour prior to reaction.
• Amount of suspect food consumed.
• Time of on-set.
• Specific symptoms experienced and the order they occurred.
• Medical or other treatment received.

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• The ingredient statement from product packaging.

• Any label statement related to a “may contain” statement and record the statement.
Inspectional follow up at the manufacturing plant may be warranted to determine if suspect
allergen is added to the product; or if the possibility of cross-contact exists.
[Link] - Veterinary Products-Complaints/Adverse Reactions
If you become aware of human illnesses associated with CVM-regulated products, contact the
appropriate ERC in your division and/or regional office immediately who will then contact the CORE
Signals Team at CORESignalsTeam@[Link].
Investigations of complaints of animal food, both medicated and non-medicated, should be
investigated like other complaints. Discuss any investigation with your supervisor. The CVM Office of
Compliance can be consulted concerning appropriate follow-up and sample collection related to
complaints.
[Link] - Sample Collection
When directed to collect a sample, collect the product which appears to have caused the injury and
an official sample from both the same and other lot codes, if available. Check with your supervisor if
you have any doubt as to the appropriateness of collecting a sample related to an investigation.
See IOM [Link].1 for routing of injury and complaint samples to the laboratory.
[Link].1 - Cosmetic Samples
Many cosmetic products such as permanent hair dyes, home permanents, deodorants, hair
straighteners, etc. are known to cause adverse reactions. Samples of these products should not
be collected except in cases of alleged severe or unusual injury (e.g., multiple complaints). In
cases of obvious allergic type reactions, samples should not be collected. For example, most
cosmetic products which get into the eye will cause temporary eye irritation and, in such cases,
a sample generally should not be collected.
[Link].2 - Microbiological Contamination
Collect samples associated with consumer complaints in which microbiological contamination is
suspected.
[Link].3 - Allergen Samples
Collect a sample if the allergen is visible (i.e., nuts,) is not declared on the label, and if deemed
necessary by division management. In all other cases, collect a sample only after consultation
with OEM/OEO (e.g., national consumer complaint coordinator) and HFP. See IOM Sample
Schedule Chart 13 in Chapter 4 for guidance on sample size. Note: the sample size may be
modified depending on product availability.

8.2.4 - Special Events

Special Events (SEs) are organized, pre-planned mass gatherings of national or international importance
that usually garner significant media coverage and are typically attended by dignitaries or public
personalities. The venues for these events are predominantly large retail food establishments such as
stadiums, arenas, convention centers, and hotels which contain retail food establishments that are
under the jurisdiction of state and local agencies. SLTTs, United States Secret Service (USSS), or the
event organizer may request FDA assistance.
See Special Event Planning Guidance (SEPG).

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NSSEs are a select group of SEs that are designated by the Secretary of the U.S. Department of
Homeland Security (DHS) to be of significant importance and may be a potential target for terrorists due
to the event’s visibility or political connection(s). The types of SEs/NSSEs supported by FDA include
Presidential inaugurations, major national political conventions, North Atlantic Treaty Organization
(NATO) and other summits of geopolitical significance, Olympic Games held in the U.S., and some major
sporting events. You may be requested to investigate food suppliers to the SE to verify compliance with
regulations. This investigation, referred to as a Supply Chain Integrity Check (SCIC), may be performed
onsite or through an online record review.

8.2.5 - Farm Investigations

A farm investigation of a raw agricultural commodity (RAC) may be conducted in response to traceback
information obtained during a foodborne illness outbreak investigation that implicates one or more
farms, ranches, packing houses, or other such operations as being involved in handling the outbreak
suspect RAC. Generally, CORE would request a domestic farm investigation through the district ERC for
the responsible OHFI contact. OII program division offices may also initiate or be assigned by HFP or OII
to perform a farm investigation as needed to protect public health. The goals of a farm investigation are
to gather information, to identify potential environmental sources of the outbreak agent, to identify
routes of contamination from potential outbreak agent sources to the implicated RAC, to observe and
document potential contributing factors to the outbreak such as practices, procedures, or conditions
that may facilitate proliferation, spread, growth, survival, or contamination by the outbreak agent, and
to support regulatory action, if appropriate.
[Link] - Approach
A team approach is utilized for a farm investigation (see IOM 5.2.8-Team Investigations). A lead CSO
should be identified from the Produce Safety Network (PSN) or the responsible OII division office
that has attended both the FD226 Produce Inspections for Regulators Course, and the FD326
Produce and Sprout Investigations for Regulators Course. A minimum of three team members
should participate and ideally all members should have produce farm training and/or produce farm
inspection experience. The appropriate state regulatory agency having jurisdiction over produce
farms should be notified and invited to participate. Additional SMEs may be added to provide
needed expertise such as wildlife, soils, agricultural water, or epidemiology. CORE, HFP Produce
Safety Staff, and/or OII HQ may assist with identifying appropriate SMEs and providing technical
guidance during the investigation.
The implicated grower should be notified in advance of the investigation as he/she or a
representative of the grower will need to be present to provide information to assist the
investigation. Generally, an FDA 482 will be issued to the grower or packing house, if different. If the
investigation expands to fields not owned by the grower, a new 482 must be issued to those
growers. Please see IOM 5.2.8 Team Investigations for additional information.
CORE has implemented formalized outbreak incident operation processes. The CORE operation
guides are available through the [Link] website.
[Link] - Sampling
A variety of environmental samples may be collected during a farm investigation, including
environmental swabs and water from both the field and the packing house, and soil and wildlife scat
samples from the growing environment. Do not collect human fecal matter unless specifically

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assigned or pre-approved to do so. In general, FDA laboratories are not prepared to receive human
feces.
Instructions for collecting soil and water samples on farm investigations are found in IOM Chapter 4,
in the Salmonella Sample Schedule Chart 1, and are also covered in FD326 (Produce and Sprout
Investigations for Regulators Training Course). Additional sampling guidance can be found in SOP-
001052 (ORA Field Bulletin #30 – Food Program Area – Instructions for Environmental Sampling),
and ORA Outbreak Response Field Guide #1 covering E. coli, Listeria, and Salmonella inspections and
investigations at sprout operations. Specific sample collection instructions or methods may also be
included in the CORE farm investigation assignment.
All environmental samples are investigational. Use the product code builder to identify the proper
code for the type of environmental sample collected, including swabs, soil, water, and animal scat.
Do not use the product code of the implicated produce for environmental samples. Produce samples
collected from the field or prior to packing (i.e., not finished product) are labeled as investigational.
Product that has completed processing on the packing line are labeled official product samples.
[Link] - Form 3623 Farm Investigation Questionnaire
FDA Form 3623, the Farm Investigation Questionnaire (FIQ), must be completed for all farm
investigations, as covered in FD3263. Some portions may not be applicable, such as the use of
biosolids. These questions may be marked as N/A. However, questions for practices that may be
used but are not currently in use should be completed by use of interview techniques with the
grower to the extent possible. The FIQ should be completed on-site to ensure all information is
collected and submitted to CORE and/or the HFP Produce Safety Staff if requested and included in
the Investigation Memo or EIR as an attachment. To avoid duplication, the FIQ may be used to
provide information under the “Manufacturing Processes” section by either reference or cutting and
pasting into that section. A short summary and flow diagram(s) describing the steps from planting
through harvesting and/or packing should be included along with this.
[Link] - Reporting
Domestic outbreak work assignments will be designated in FACTS as either an operation 12
inspection (OP12) or an operation 13 investigation (OP13). Foreign outbreak work assignments will
be designated in FACTS as either an operation 11 inspection or an operation 15 investigation.
For FACTS operation 11 or 12 farm inspections see Chapter 5 for reporting; however, if an outbreak
is ongoing and the information is needed immediately, it may be necessary to prepare a separate
memo to submit to CORE prior to completing the EIR.
For FACTS operation 13 or 15 investigations, follow reporting guidance in this chapter.

8.2.6 - Infant Formula and Baby Food

There is a continued sensitivity to all reported incidents involving infant formula and baby food. All
complaints involving either infant formula or baby food are to be immediately escalated following SOP-
000544. Appropriate follow-up with the consumer, potential inspection of the manufacturer, and
follow-up with the doctor or
hospital if appropriate should be done. Samples can be collected as part of the follow-up. Complaints
involving baby food regulated by USDA should be referred to USDA for appropriate follow-up. See IOM
9.2.1. There are two exceptions for collecting samples as part of the follow-up to infant formula/baby
food complaints. Do not collect samples unless directed for:

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• Complaints involving outdated product in the marketplace with no associated injury or illness
only require investigation to ensure all outdated product has been removed from the identified
retail and/or wholesale source.
• Complaints involving an illness associated with normal appearing product when the follow-up
investigation discloses that the event does not appear to be product related or was an allergic
response to a properly labeled product per a physician's diagnosis. When complaints involving
food products intended for infants are received, NOT-000210 should be reviewed to verify if it
meets criteria in the memo.

8.2.7 - Tampering Involving Alcoholic Beverages

All tampering complaints involving alcoholic beverages should be entered as a consumer complaint.
OEM/OEO and OCI should be notified immediately following SOP-000544. OEM/OEO can be notified by
e-mail at [Link]@[Link] and by phone 24 hours a day at 1 (866) 300-4374.
For all other complaints involving alcoholic beverages, please see IOM [Link] for guidance.

8.3- Drug Investigations

8.3.1 - Investigations Coordination
The following procedures should be followed for investigating suspected adverse drug reactions,
including drug-induced birth defects:
• If you are interviewing the consumer, conduct the normal complaint investigation and gather all
pertinent information regarding the product, patient, adverse event, etc. If the consumer
received medical treatment, obtain a medical records release (Exhibit 8-2). Reporting of drug
adverse experiences is voluntary and you should encourage and assist complainants and health
care providers to complete the MedWatch form (FDA 3500) (see Exhibit 8-7) and submit to
MedWatch. Report your findings in the FACTS Consumer Complaint follow-up screens and in a
memo of investigation.
• If you are investigating an adverse reaction at the manufacturer, conduct your investigation to
determine whether the adverse event was caused by a drug quality defect. Determine if the
manufacturer was aware of the complaint, has investigated, and per IOM 5.14.4 Adverse Event
Reporting has submitted the reportable event to FDA. For additional information regarding
DQRS (MedWatch Reports) and NDA FARS (New Drug Application Field Alert Report) see the
applicable compliance program in the Compliance Program Guidance Manual (CPGM).
Determine if the manufacturer is aware of any similar reported events. Collect current labeling
of the product to determine whether this was an expected or unexpected adverse event. Your
findings will be reported through the FACTS Consumer Complaint follow-up screens and a memo
of investigation or EIR.
• You may also be directed to conduct investigations at other establishments, such as pharmacies,
doctors’ offices, or distributors. Conduct your normal complaint investigation determining each
party’s role and involvement. If individuals interviewed are not required to report adverse drug
reactions, encourage and assist them to complete and submit the FDA 3500 form to MedWatch.
In all cases of suspect drug-induced adverse reactions, the center will review the information on the FDA
3500 form and will issue assignments to the field if additional information is needed.

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8.3.2 - Illness/Injury
Drug injuries or reactions, either human or veterinary, result from the use of products which may:
• Vary markedly from declared potency.
• Contain deleterious substances.
• Be mislabeled as to identity, warnings, or instructions.
• Have been mistaken for other drugs despite proper labeling.
• Have changed composition or become contaminated after shipment.
• Be dangerous when used according to directions.
• Have not been used in accordance with label directions or directions from the prescriber.
• Have been improperly administered or administered without the necessary precautions.
• Have been contaminated with objectionable microorganisms, soaps, or cleaning solutions.
• Have been misidentified.
• Be labeled as sterile drugs but are found to be non-sterile.
• Have adverse effects that were not identified prior to marketing.
[Link] - Reporting
[Link].1 - Reporting Forms – Drugs
Submit drug complaints and injuries to:
MedWatch
The FDA Medical Products Reporting Program (HFD-410)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Fax Number: 301-827-7241
[Link].2 - Reporting Forms – Veterinary Products
Submit veterinary injuries or adverse reaction reports to:
Food and Drug Administration
Center for Veterinary Medicine
Division of Surveillance (HFV-210)
7500 Standish Place
Rockville, MD 20857
In addition, follow specific reporting instructions as indicated per an assignment.

8.3.3 - Complaints
The FDA Office of Emergency Management/Office of Emergency Operations (OEM/OEO) HFA-615, 301-
796-8240 must be notified immediately of all life-threatening injury/illness, death, and suspected
tampering complaints. This may be accomplished by adding the OEO team name to the CMS OII
Consumer Complaint Initial Disposition Decision, per SOP-000544.
• Injury/illness complaints
o Any illness/injury related to infants should be considered high priority. These complaints
are to be thoroughly investigated.
• Complaints and adverse reactions associated with veterinary products including animal drugs,
medicated feeds, and medical devices for animals are handled through the FDA CVM Division of

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Veterinary Product Safety (HFV - 240). Veterinarians, animal owners, and drug manufacturers
may report problems to their local FDA district offices or directly to CVM. The division should
advise the complainant to complete an FDA 1932a, "Veterinary Drug Adverse Experience, Lack
of Effectiveness or Product Defect Report" for drug adverse events associated with unapproved
animal and approved human drugs and veterinary devices. For approved animal drugs, the
complainant should be instructed to call the manufacturer directly to report the event. Detailed
instructions and options for different case scenarios are available at
[Link]
For 3-day Field Alert Reports (FAR), drug sponsors now have the option to electronically submit 3-Day
field alert reports (FARs) directly to CVM. CVM will receive the electronic 3-Day FAR from the sponsors
and will automatically generate and email a .pdf of the FAR with associated attachments to the
appropriate district office. Some sponsors may still send the 3-day FAR through the traditional route to
the district office. The district office should email the form and any other attachments to CVM. The
drug manufacturer should notify and submit the FAR to their respective district office within three days.
The district offices will ask for additional information if necessary and submit the 3-day FAR to the
Division of Veterinary Product Safety.
Complaints and adverse reactions associated with animal feeds including pet food products are handled
through the Division of Compliance (HFV-230) at CVM. Veterinarians, animal owners, and firms may
report pet food problems to consumer complaint coordinators at their FDA district office or OEM/OEO;
the district will complete a CMS Consumer Complaint Report and follow SOP-000544 for escalation. Pet
food reports may also be made directly to CVM using FDA’s Safety Reporting Portal. Instructions for
stakeholders to report problems associated with pet food products are available at
[Link] If you become
aware of human illnesses associated with CVM-regulated products, contact the appropriate ERC in your
division and/or regional office immediately who will then contact the CORE Signals Team at
CORESignalsTeam@[Link].

8.4 - Device Investigations

8.4.1 - Injury/Illness
When investigating incidents implicating medical devices, you must first confirm whether the device was
a contributing factor. An appropriate follow-up, such as an inspection at the manufacturer may be
necessary. The cause of medical device injuries may originate with the manufacturer, operator, user, or
from other factors including, but not limited to, the transportation or installation of the device.
Additionally, an illness may occur as a result of device specifications not being met, such as a device
labeled as sterile not meeting sterility requirements.
Obtain the following information for medical devices:
1. A complete description of the incident (sequence of events) and the injury/illness, including:
a. UDI, Type, model, serial number and manufacturer of the device, and copies of any labeling
for the specific device(s) involved including instructions for use or operations manual(s).
b. Details of the alleged incident, including number of people involved; symptoms, onset time,
duration, and outcome; date and time of occurrence; reports of other investigating agencies
and their conclusions, (e.g., fire marshal or OSHA reports); similar incidents which may have
resulted in injury/illness; and all operational SOPs, written or unwritten.

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2. Copies of medical records and/or laboratory records. Use an FDA 461, Authorization for Medical
Records Disclosure, IOM Exhibit 8-2, signed by the patient or other authorized person, when
obtaining these records.
3. Official cause of death, death certificate, and/or autopsy report, if indicated.
4. Determine if the device malfunctioned, and the cause.
5. The condition of the device at the time of use. Review its maintenance history, including
responsibility for maintenance (past and present), special service calls, repairs, whether
component warning or safety systems were functional, maintenance records, changes or
corrections accomplished just prior to or immediately after the incident, and who performed the
activity. An interview with biomedical engineering department personnel may be indicated.
6. Who has access to the device? Determine if individuals using the device are familiar with its
operation.
7. The results of any examination or inspection of the device by the hospital or other party to
determine the cause of the incident.
8. Whether there are other devices of the same model number or lot number on the premises.
[Link] - Types of device injuries or illnesses include:
[Link].1 - Mechanical, Electrical, or Electromechanical Devices
Injuries caused by mechanical, electrical, or electromechanical devices may result from devices
that:
• Do not conform to specifications due to mistreatment (e.g., damage in transit), or failure
to comply with good manufacturing practices.
• Malfunction due to incorrect installation.
• Have not been used in accordance with labeled instructions.
• Have been used/installed with incompatible accessories or parts which are not
compatible.
• Have been used under conditions which interfere with their ability to function (e.g.,
electromagnetic interference (EMI), fluid seepage into electrical circuits, etc.).
• Have been damaged during use, or random failures.
• Have not been adequately designed for intended use (unstable, poor structural
integrity, electrical leakage, reusable but unable to thoroughly clean, etc.).
• Do not contain adequate directions or warnings.
• Are intended to be sterile but are non-sterile.
• Fail or deteriorate for any reason.
[Link].2 - Devices for Implant
Causes of injuries which may result from implanted devices include those listed in IOM [Link].1.
An injury or illness may also result because the materials used in the implant are not
biocompatible, thereby causing an adverse tissue reaction and/or deterioration of the implant.
It is important to obtain information relating to a medical professional’s interpretation of the
relations.
[Link].3 - In-Vitro Diagnostic Devices
In Vitro Diagnostics (IVD) are instruments that can include, gas chromatographs and automated
blood analyzers, and much of the information under IOM [Link].1 is applicable.

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Injuries to patients from IVD products may be considered indirect because they are due to
complications resulting from misdiagnosis or delays in patient treatment due to incorrect test
results. Examples of IVD failures include false positives, false negatives, and erratic results. Poor
performance or failure may be due to poor manufacturing practices or user error.
Manufacturing problems include:
• Process errors and mix-ups (varying fill in kit components, improper ingredient addition,
etc.).
• Labeling does not contain adequate directions or warnings or contains incorrect
information.
• Labeling mix-ups.
• Contamination making the product unusable or causing misdiagnosis.
• User error due to poor directions for use, operator’s manual, or inadequacies in labeling
requirements.
• Use of unclean, not maintained, or improperly calibrated equipment.
• Improper storage or use of reagents.
For In Vitro Diagnostic devices determine:
1. How the results of the test are used; screening, therapeutic drug monitoring,
epidemiological information, monitoring the course of a disease, etc.
2. The role in overall determination of patient clinical care.

8.4.2 - Confidential Sources

FDA may receive external complaints that request their identity to be kept confidential or anonymous.
In this case, the complainant’s information should not be disclosed in the investigation memorandum or
EIR. The complaint should be assessed to determine if it is a non-injury/illness complaint, life-
threatening injury/illness complaint, non-life-threatening injury/illness complaint, or death complaint as
this may impact the urgency of the response. An immediate follow-up may be warranted if there is
illness, injury, death, or if directed by higher authority. All information should be obtained in the least
intrusive, yet constructive, manner that allows the investigator to collect the evidence required to
evaluate the validity of the complaint to determine if additional action is warranted.

8.4.3 - Complaints
FDA may receive information from various sources, such as a consumer, whistleblower, employee, other
governmental agency, Congress, or competitor alleging a potential violation of the FD&C Act that must
be followed up to confirm the information provided by the complainant. For medical devices, a
complaint means any written, electronic, or oral communication that alleges deficiencies related to the
identity, quality, durability, reliability, safety, effectiveness, or performance of a device after it is
released for distribution.
As with all investigation types, report your findings in a memorandum and include all pertinent
information and any attachments collected as evidence to support the complaint. Using eNSpect, create
an operation 13, domestic investigation, or operation 15, foreign investigation, utilizing only one FEI and
the Investigation Basis of Consumer Complaint, and complete all required fields. Upload all labeled
attachments and submit for endorsement by your supervisor. Ensure the consumer complaints tab in
eNSpect is completed. If foreign, ensure the center is notified of the investigation and receives a copy of
the investigation memorandum and any attachments.

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If the complaint is an adverse reaction to a device, advise the complainant to visit [Link], specifically
the MedWatch Online Voluntary Reporting Form ([Link]) to complete an FDA 3500, MedWatch Form;
[Link] (See IOM Exhibit 8-7) and discuss the need
to have physician complete the form for submission. If the physician will not cooperate by completing
the FDA-3500, request the complainant to do it. Note in the "Remarks" section of the CMS Consumer
Complaints Report that the FDA 3500 was forwarded to the complainant.

8.4.4 - Reporting
The Medical Device Reporting (MDR) regulation and the changes mandated by the Safe Medical Devices
Act of 1990 (SMDA) is a mandatory information reporting system. It requires manufacturers, importers,
and device user facilities to report to FDA certain adverse experiences caused or contributed to by their
devices.
This program is administered by the Center's MDR Policy Team in the Office of Regulatory Programs.
The regulation requires a report be submitted to FDA whenever a manufacturer or an importer becomes
aware of information that its device: 1. May have caused or contributed to a death or serious injury, or
2. Has malfunctioned and this device or a similar device would be likely to cause or contribute to a death
or serious injury, if the malfunction were to occur.
Under the Safe Medical Devices Act of 1990, user facilities must report device-related deaths to FDA and
to the manufacturer, if known. User facilities must also report device-related serious illnesses and
injuries to the manufacturer, or to FDA if the manufacturer is unknown. In addition, SMDA also requires
user facilities to submit to FDA, on an annual basis, a summary of all reports submitted.
The CDRH Division of Industry and Consumer Education (DICE@[Link]) and the MDR Team
(MDRPolicy@[Link]) in the Office of Regulatory Programs should be contacted for further guidance
about the MDR regulation.
As of August 2018, the agency’s Voluntary Malfunction Summary Reporting program was implemented.
It permits certain manufacturers an alternative method to submit MDRs for eligible product codes in
summary form on a quarterly basis; see 83 FR 40973.

8.4.5 – Medical Device Sampling

Obtain CDRH and WEAC concurrence prior to collecting any medical device samples.

8.5 - Biologics Investigations

8.5.1 - Illness/Injury
Reactions or symptoms of illness may occur in association with the administration of vaccines and other
biological products. The Center for Biologics Evaluation and Research (CBER) is interested in all
unexpected clinical responses to a biological product, as well as any expected responses of unusual
frequency or severity. In some cases, a reaction or illness could occur because the product may:
• Vary from declared potency.
• Have been contaminated during manufacturing, shipment, or after shipment.
• Be mislabeled.
• Not have been given according to directions.
• Not have been stored under proper conditions.
• Have been provided to the wrong person.

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• Contain substances innocuous to most people, but which the recipient is unable to tolerate
(e.g., anti-Kidd, anti-Duffy), or contains substances not usually present in such a product which
stimulate an adverse response in the recipient (e.g., HLA antibodies).
[Link] - Reporting
[Link].1 - Investigation/Reporting
When a biologics reaction/injury complaint is received by a CSO, they should forward the
complaint to OIIOBIBiologicsInspectionPOC@[Link]. The Biologics POC will then forward it
to the appropriate OII Consumer Complaint Coordinator following SOP-000544.
All complaints received by the OII BIO Biologics Inspection POC will be reviewed and upon
determination of initial follow-up status entered into the OII Consumer Complaint Initial
Disposition Work Activity for that complaint.
When interviewing the complainant about a biologics complaint /injury, obtain:
• Complete description of the complaint/injury.
• Onset and duration of the reaction/injury.
• Name of product administered, include date and time of administration.
• Manufacturer and lot number of product(s), if available.
At this point, it is generally unnecessary to conduct interviews beyond the complainant, or
obtain records, until a preliminary review has been conducted. It is important to rapidly
communicate the basic information about the incident, implicated product, lot, license number,
manufacturer, and presence of intact units to OIIOBIBiologicsInspectionPOC@[Link].
Confidential complaints received during an inspection should be captured in a memorandum as
an attachment to the EIR. The confidential source information should not be referenced in the
EIR. Any findings related to complaints not involving confidential sources should be documented
in the narrative to the EIR. The complaint number for all complaints should be written in the EIR
coversheet in eNSpect. Complaint follow-up assignments will be issued in eNSpect as
determined by OBI.
If a complaint related to a vaccine product involves an adverse reaction of any kind, then a Form
VAERS-1 (IOM Exhibit 8-6) should be completed online by complainant or their physician. If they
cannot complete the form online, the VAERS Reporting Form can be mailed to them and they
can send it to the address on the form. When you send a VAERS form to a complainant, note this
fact in the Remarks Section of the CMS Consumer Complaint Report.
The Vaccine Adverse Event Reporting System (VAERS) is administered under a joint FDA/CDC
contract. For reporting adverse events which occur subsequent to vaccine administration, the
system utilizes a fillable online form (Form FDA VAERS 2.0) or can be directly submitted at:
[Link] See IOM Exhibit 8-6.
[Link].2 - Professional Reporting System for Vaccine Adverse Reactions
The National Childhood Vaccine Injury Act of 1986, 42 USC 201, was passed to achieve optimal
prevention of childhood infectious diseases through immunization. At the same time, it was
intended to minimize the number and severity of adverse reactions to vaccines routinely
administered to children. This law requires health care providers and vaccine manufacturers to
report certain adverse events which occur following the administration of specific vaccines. The

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vaccines and reportable events are listed in the National Childhood Vaccine Injury Act Vaccine
Injury Table. The Department of Health and Human Services (DHHS) has established a Vaccine
Adverse Events Reporting System (VAERS) to accept all reports of suspected adverse events
after the administration of any vaccine, in all age groups, including but not limited to those in
the table.
If the complaint does not involve an adverse reaction, obtain the necessary information to allow
the center to make an informed decision on follow-up at the manufacturer.
If the complaint is an adverse reaction to a biologics device, drug, or HCT/P product, an FDA
3500, MedWatch Form (See IOM Exhibit 8-7) must also be completed and forwarded to the
complainant for completion by their physician. If the physician will not cooperate by completing
the FDA-3500, request the complainant to do it. Assist the complainant in completing the FDA
3500, if necessary. Note in the "Remarks" section of the CMS Consumer Complaints Report that
the FDA 3500 was forwarded to the complainant. MedWatch forms can be found at
[Link]
reporting.
If the complaint does not involve an adverse reaction, obtain information necessary to permit
OBI make an informed decision on follow-up at the manufacturer. If a complainant desires
further information, refer them to CBER, Office of Biostatistics and Epidemiology, Division of
Epidemiology, at 301-827-3974.
If a CSO finds that there is a complaint of a fatality where blood or a blood component is
implicated and that was not already reported to CBER, the CSO should notify their supervisor.
The supervisor will then follow-up with OBI management and CBER. Reporting a fatality is
required of the collecting facility, in the event of a donor reaction, and by the facility which
performed the compatibility tests, in the event of a transfusion reaction. An investigation of the
incident shall be conducted by either Healthcare Finance Administration (HCFA) Centers for
Medicare and Medicaid Services (CMS) or FDA, based on the type of facility involved, for
example, transfusion service, blood bank, plasma center or hospital. OBI CSOs may be assigned
to investigate a fatality through an assignment from CBER.
CSOs should follow OBI’s procedure as a guide for conducting the investigation. The CSO should
also refer to the eNSpect assignment for additional information regarding the investigation. If
the hospital, medical examiner, or other entity either refuses to provide or requires a written
request in order to provide the CSO with medical history records, a death certificate, autopsy
report, or other needed records, the CSO should complete and provide the firm with the
Records Request Letter, that is referenced in OBI’s procedure.

8.5.2 - Surveillance
OBI CSOs should review OSAR Firm 360 to determine if an existing complaint exists in preparation for
conducting an inspection assignment. The CSO will review all firm information in OSAR Firm 360,
including reviewing all complaints and address all complaints that do not have entries under follow-up
disposition and follow-up disposition dates during the inspection assignment. Complaints related to the
FEI that have an initial evaluation of FDA Action Indicated, an initial disposition is entered, and no
follow-up disposition is entered will automatically be listed into the inspection assignment following
SOP-000544. CSO conducts the establishment inspection and investigates those issues identified in the

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complaint(s) and includes observations in the summary sections in the narrative of the EIR and
completes the consumer complaints tab in eNSpect.

8.5.3 - Confidential Informants

In addition to this section, please refer to the general section on Confidential Sources (see IOM
[Link].2.3). Complaints can originate from public sources, including establishment employees at firm’s
we inspect, donors, donor family members, and industry. Confidential complaints can also come
through CBER and through other agencies. If the complaint is from a confidential source, the complaint
information is NOT documented in the EIR. Confidential Source complaint information is documented in
an Investigation Memo and saved as an attachment to the EIR. Findings are considered in the initial
classification of the inspection.

8.5.4 - Complaints
[Link] - Biological Products
OBI CSOs should follow the OBI procedure on oversight of consumer complaints. If a consumer
complaint coordinator receives a complaint on a biological product, they will follow SOP-000544 for
proper escalation to the Biologics CMS team. If any OII Office receives a complaint on a biological
product, regardless of licensure status, the receiving office will notify OBI at
OIIOBIBiologicsInspectionPOC@[Link]. OBI will provide direction on how to proceed, and next
steps, including instructions on any CMS entries. For additional information or inquiries, send an
email to the inspection POC address above or contact either of the OBI division directors. OBI staff
receiving a complaint from external or internal sources should send the complaint to
OIIOBIBiologicsInspectionPOC@[Link]. Confidential complaints received during an inspection
should be captured in a memorandum as an attachment to the EIR. The confidential source
information should not be referenced in the EIR.
Any findings related to complaints not involving confidential sources should be documented in the
narrative to the EIR. The complaint number for all complaints should be written in the EIR
coversheet in eNSpect. The consumer complaints tab in eNSpect must be completed for any
assignments with complaints. Complaint follow-up assignments will be issued in eNSpect as
determined by OBI.
[Link] -Biological Samples
Do not collect samples of a suspect product without first consulting with the supervisor. An
evaluation of the preliminary information on the injury/reaction by CBER (for licensed products)
and/or the home district division (for unlicensed products, plasma, and blood products) may be
necessary to determine if a sample should be collected.
[Link] – Biological Injury/Adverse Reaction Reports
Submit biologics injury and adverse reaction narrative reports using encrypted email or mailing. If
mailing, use this address:
Food and Drug Administration
White Oak Bldg71
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

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NOTE: In addition, check the “Notify EO/EOMPS?” box in FACTS for all injury and adverse reaction
complaints. For serious injury/illness reports, please notify the OEM/OEO immediately at 1 (866)
300-4374 and [Link]@[Link].

8.6 - Bioresearch Monitoring Investigations

8.6.1 - Illness/Injury
[Link] - Reporting
Submit drug complaints and injuries to:
MedWatch
The FDA Medical Products Reporting Program (HFD-410)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Fax Number: 1-800--322-0178

8.6.2 - Surveillance
For Cause assignments issued to OBMI may require interviewing of subjects to verify their participation
in the clinical trial. These activities would be conducted with supervisor approval. An OP13 (or OP15 for
foreign) will be created in eNSpect, for the purpose of subject interviewing, with information correlating
the OP12 (or OP11) For Cause assignment. An investigational memo will be uploaded as an
“Attachment” as per IOM 8.1.9 General Investigation Reporting. Additionally, the investigational memo
will be included in the EIR as an “Attachment.”
8.6.3 - Complaints
Complaints are received via assignment memo from the respective center. The memo will have specifics
about the complaint and any special instructions. Reporting of complaints are the same as an inspection
via an EIR unless otherwise instructed (see section regarding For Cause/Fact Finding/Information
Gathering above). See IOM 5.14.2 – BIMO Assignments as complaint information will be included in the
overarching assignment memo.

8.7 - Tobacco Investigations

8.7.1 - Investigations Coordination
Tobacco Products Samples: When collecting tobacco product samples as a result of a product complaint
or adverse report investigation, see IOM Exhibit 4-24, for sample collection guidance and contact CTP’s
Office of Compliance and Enforcement.

8.7.2 - Complaints
Anyone who encounters a problem with a tobacco product, such as a safety issue, undesired health
problem, or product defect may report it online via the FDA Safety Reporting Portal (SRP) at
[Link]
Potential tobacco product violations include (but are not limited to):
• Sales to minors.
• Flavored cigarette sales.

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• Illegal marketing and advertising – The Tobacco Control Act gives the FDA the ability to regulate
certain marketing and advertising activities by the tobacco industry, including
• describing tobacco products as “light,” “mild,” or “low” – or claiming a product is safer or less
harmful without an FDA order.
• Distributing t-shirts or other promotional or novelty items with brand names of cigarette or
smokeless tobacco products.
• Sponsoring events using the brand names of cigarette or smokeless tobacco products.
• Distribution of free samples of tobacco products except in limited circumstances.
• Placement of cigarette or smokeless tobacco product vending machines in prohibited areas (or
providing access to self-service or direct access of tobacco products in prohibited areas).
• Sale of cigarettes in packages of less than 20.
If you see what you believe to be a violation of the Tobacco Control Act or other related regulations, you
can:
• Submit online ([Link]
• Call the Tobacco Call Center using CTP's toll-free number: [Link].1373
• Send an email: CTPCompliance@[Link]
• Print and mail:
Paper form (Form FDA 3779, Potential Tobacco Product Violations Report)
([Link] to:
Potential Tobacco Products Violation Report
Food and Drug Administration
Center for Tobacco Products
Office of Compliance and Enforcement
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993

57
EXHIBIT 8-1 INVESTIGATIONS OPERATIONS MANUAL 2025

8-1 - FEDERAL ANTI-TAMPERING ACT FULL LANGUAGE

58
INVESTIGATIONS OPERATIONS MANUAL 2025 EXHIBIT 8-1

8-2 - LETTER TO HEALTHCARE PROVIDER FOR MEDICAL RECORDS

To access the word document, click here. Note: Link to the Letter to Healthcare Provider for Medical
Records is only available to OII users on the FDA intranet. The link is
[Link]
uid=ANONYMOUS&mcsid=FPSFER5OBBABVCT55K.

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EXHIBIT 8-3 INVESTIGATIONS OPERATIONS MANUAL 2025

8-3 - INVESTIGATION MEMO

To access the word document, click here. Note: Link to the Investigation Memo is only available to
OII users on the FDA intranet. The link is
[Link]
mcuid=ANONYMOUS&mcsid=AQZ6DL5KXFHKBPWISH. Users who need a copy of the SOP outside FDA
should use the Freedom of Information Process. See IOM 8.1.3 to get a copy of the SOP.

60
INVESTIGATIONS OPERATIONS MANUAL 2025 EXHIBIT 8-3

Import Investigation Memo Example (Failure to Hold)

61
EXHIBIT 8-3 INVESTIGATIONS OPERATIONS MANUAL 2025

62
INVESTIGATIONS OPERATIONS MANUAL 2025 EXHIBIT 8-3

63
EXHIBIT 8-4 INVESTIGATIONS OPERATIONS MANUAL 2025

8-4 - TABLE OF INCIDENT COORDINATION

Incident Type Coordinating Body Points of Contact (POCs)

Clusters and outbreaks of 2+ HFP/ CORE CORE Signals Team,
human illnesses (Coordinated Outbreak CORESignalsTeam@[Link]
Response and Evaluation
Network)

Single human illness (this HFP / OCE hfp-oce-outbreak-

includes single case (Office of Compliance) alert@[Link]
retrospective incidents but
also individual consumer
complaints)

Clusters and outbreaks of CVM [Link]@[Link],

human illness due to pet (Center for Veterinary [Link]@[Link]
food/feed products Medicine)

Allergen issues (any and all) HFP / OCE [Link]@[Link]

(Office of Compliance)

Seafood toxin incidents* HFP / OFS / DSS [Link]@[Link]

(All toxins; All domestic and (Division of Shellfish Safety [Link]@[Link]
international waters) and DSST, Division of Seafood [Link]@[Link]
Science and Technology)

Molluscan shellfish outbreaks HFP / OFS / DSS [Link]@[Link] (goes

(single and multiple human (Division of Shellfish Safety by Lizzie; OFS / DSS)
illnesses) and DSST, Division of Seafood [Link]@[Link] (OFS /
Science and Technology) DSS)
[Link]@[Link] (OFS /
DSST)
Processed shellfish outbreaks HFP/ CORE CORE Signals Team,
(e.g., non-molluscan shellfish (Coordinated Outbreak CORESignalsTeam@[Link]
(crustaceans such as lobster, Response and Evaluation
crab, crab meat, crawfish, Network)

64
INVESTIGATIONS OPERATIONS MANUAL 2025 EXHIBIT 8-4

shrimp, and processed

molluscan shellfish))

Kratom-related / CBD / OC / OO / OSEM / OEM / OEO FDA Emergency Operations list:

psychoactive substance (Office of Emergency [Link]@[Link]
incidents Operations)

Hepatitis A positive samples FDA Liaison to CDC FDA Liaison to CDC

(and subsequent coordination ([Link]@[Link])
with CDC for PEP); no known
associated HAV illnesses

Infant illnesses* (Salmonella, HFP / OC OC contact for PIF is

Cronobacter, infant botulism (Office of Compliance) - [Link]@[Link]
with rule-out investigations for Powdered Infant Formula (PIF) ONFL contact for infant formula are
infant formula or related [Link]@[Link] and
HFP / ONFL
infant products such as gripe [Link].@[Link]
water or medicated foods) (Office of Nutrition and Food
Labeling) NCCC in OEO is
[Link]@[Link]
NCCC
National Consumer Complaint
Coordinator

Disasters (Natural and OC / OO / OSEM / OEM / OEO FDA Emergency Operations list:
Manmade) (Office of Emergency [Link]@[Link]
Operations)

Food Defense incidents OC / OO / OSEM / OEM / OEO HFP/OAO/Food Defense and

(Intentional Contamination) (Office of Emergency Emergency Coordination Staff
Operations) contact is
[Link]@[Link]
And
HFP / OAO
(Office of Analytics and
Outreach)

65
 EXHIBIT 8-5 INVESTIGATIONS OPERATIONS MANUAL 2025

8-5 - CIFOR OUE Agent List

Agent Name Median Incubation Primary Signs and Primary KEI§-Special KEI-Geographic KEI-Notable
Symptoms Specimen(s) Considerations Exposures
Period (Range)1 group(s)
BACTERIAL
Arcobacter butzleri 32 hrs (6-83 hrs)2 D (persistent and watery), Stool in Cary-Blair,
abdominal cramps, N, V raw stool
Bacillus anthracis Usually ≤1 week (Up Severe abdominal pain, N, V, Blood, stool in Cary- Recent travel to Undercooked meat
to 60 fever, D (may be bloody), Blair, raw stool endemic areas, or hides of
days) ascites, sepsis, meningitis tropical or sub- herbivores
temperate
regions
Bacillus cereus, diarrheal 10-16 hours (6-24 Abdominal cramps, D Stool in Cary-Blair, Time and/or
toxin hours) (watery), N raw stool temperature-
abused foods
Bacillus cereus, pre-formed 30 min- 6 hours Sudden onset of severe N, V, Stool in Cary Blair Time and/or
toxin D temperature-
abused foods
Brucella spp. 3-4 weeks (1 week to Flu-like symptoms including Blood, serum Animal Ingestion of raw
several months) fever, chills, sweating, HA, handlers, milk and dairy
joint pain, weakness; may especially farm products
cause recurrent fevers and workers and
chronic joint pain/fatigue; veterinarians
may cause diarrhea and
bloody stools in acute phase
Campylobacter spp. 2-5 days (1-10 days) D (may be bloody), Stool in Cary Blair, Undercooked or raw
abdominal cramps, Fever, raw stool meat or poultry;
possible N & V, Guillain- raw milk/ milk-
BarreSyndrome3 products

Clostridium botulinum, 12-72 hours (6 hours- V, D, blurred vision, diplopia, Raw stool, Improperly
foodborne£ 10 dysphagia, "bilateral" vomitus, or processed and
days) descending muscle serum canned foods in
weakness, cranial nerve (specimens airtight
palsies (e.g., blurred vision, collected prior to containers/packagin
diplopia, dysphagia) anti- toxin g
administration)

Clostridium botulinum, 3- 30 days Lethargy, weakness, poor Raw stool, serum Infants Honey; home
feeding, constipation, canned vegetables,
infantile£
hypotonia, poor head fruits; corn syrup
control, poor gag reflex and
sucking reflex
Clostridium perfringens 8-16 hours (6-24 D (watery), abdominal Stool in Cary- Time and / or
hours) cramps, N; Blair, raw stool temperature
fever is rare abused foods

Cronobacter sakazakii Bacteremia, meningitis, Blood, stool in Premature Infant formula

Less than 28 days necrotizing enterocolitis Cary- Blair, raw infants
stool
Coxiella burnetii (Acute Q 2-3 weeks (3-39 days) Fever, HA, fatigue, malaise, Blood with EDTA/ Pregnant Consumption of raw
fever) cough, anorexia, N, V, D, serum, tissue women, cow or goat milk;
abdominal pain, pneumonia immunosuppr contact with cows
essed, and or goats
patients with a
pre-existing
heart valve
defects

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 INVESTIGATIONS OPERATIONS MANUAL 2025 EXHIBIT 8-5

Enterohemorrhagic E. coli 3-4 days (1-10 days) D (often bloody), abdominal Stool in Cary- Young children Consumption of raw
(EHEC) (including Shiga-toxin cramps, V, hemolytic- Blair, raw stool milk; contact with
producing E. coli (STEC) and uremic syndrome (HUS) cattle/ruminants;
Verotoxin producing E. coli undercooked
(VTEC)) ground beef; leafy
greens

Enterotoxigenic E. coli 24-72 hours (10 D (profuse watery), Stool in Cary- Foreign travel Contaminated water
(ETEC) hours- 6 abdominal cramps, V Blair, raw stool especially to and food sources
days) developing
countries
Enteroinvasive E. coli (EIEC) As short as 10-18 hrs D (watery), fever, abdominal Stool in Cary- Foreign travel
cramps, dysentery (in rare Blair, raw stool especially to
cases)- scant stools w/ developing
evidence of blood, mucous countries
or leukocytes in stool

Enteropathogenic E. coli As short as 9-12 hrs D (watery with mucous), Stool in Cary- Children < 2
(EPEC) fever, V Blair, raw stool years of age

Enteroaggregative E. coli Estimated at 20-48 Chronic or acute D (watery), Stool in Cary-

(EAEC) hrs V Blair, raw stool

Diffuse-Adherence E. coli D Stool in Cary- Young children

(DAEC) Blair, raw stool
Leptospira interrogans 5-14 days (2-30 days) Anicteric disease (no liver Blood, CSF, Urine Farmers, Water activities
involvement)- Abrupt onset veterinarians, (swimming,
of fever, HA, abdominal slaughterhous kayaking)
pain, N, V, severe myalgia, e, and sewer
malaise, conjuctival workers
petechiae and/or
hemorrhage Icteric disease
(liver involvement)-
Jaundice, upper right
quadrant pain, N, V,
decreased urine output,
edema, hemorrhage,
vascular collapse, severe
altered mental status (AMS)
Listeria monocytogenes 1 day- 3 weeks (3-70 Invasive disease- Blood, CSF, Stool Pregnant Raw milk/dairy; soft
days) Severe HA, N, V, stiff in Cary-Blair women€, cheeses; deli or RTE
neck, confusion, and immunosuppr meats, raw produce
other neurological
essed¥,
symptoms consistent
with meningitis, sepsis, elderly¥
bacteremia, premature
birth, or stillbirth
Gastrointestinal disease-
Fever, D, myalgia
Mycobacterium bovis Undetermined Gastrointe Stool in Cary- Foreign born, Raw milk/milk
stinal Blair, sputum immigrants, products; contact
disease- immunocompr with cattle, bison,
Abdominal omised, dairy elk, and deer
pain, D workers
Lung disease- Fever, weight
loss, night sweats, cough
Salmonella spp. (non-typhi) 12-36 hours (6- 72 D (can be bloody) fever, Stool in Cary-
hours) abdominal pain, N, V Blair, raw stool
Salmonella Typhi/ Typhi- 7-14 days (3- Fever, HA, malaise, chills, Stool in Cary- Recent travel to Contaminated water
Paratyphi 60+ myalgia, weight loss, Blair, raw stool endemic areas; and food sources
days)

67
 EXHIBIT 8-5 INVESTIGATIONS OPERATIONS MANUAL 2025

Paratyphi- 1-10 days constipation or D, Africa,

bacteremia, rash, cough Southeast Asia

Shigella spp. 24-72 hours (1-7 D (stools can have blood and Stool in Cary- Young children Usually person to
days) mucus), abdominal cramps, Blair, raw stool person,
fever, V, tenesmus water or raw milk

Staphylococcus aureus 1-6 hrs (30 minutes- Severe N, V, abdominal Stool in Cary- Foods handled with
(preformed toxin) 8hrs) cramps, prostration, D, drop Blair, raw stool bare hands
in blood pressure especially those
without further
cooking or
inadequate
heating/
refrigeration, time
and / or
temperature abused
foods
Streptococcus, Group A 1-5 days Sore throat (pharyngitis, Throat swab Milk/ raw milk,
tonsillitis), fever, malaise, eggs, raw
rash, cellulitis produce
Vibrio parahaemolyticus 12-24 hours (2-96 D (watery), N, V, abdominal Stool in Cary- Immunocompr Coastal, Raw or
hours) cramps, HA, fever, chills; Blair, blood, omised, pre- brackish undercooked
Wound infections are wound culture existing liver waters, seafood (oysters,
possible conditions estuaries clams, squid,
mackerel, tuna,
sardines, crab,
shrimp)
Vibrio vulnificus 24-72 hours (1-7 V, D, abdominal pain, wound Stool in Cary- Immunocompr Coastal, Raw or under-
days) infections, bacteremia, Blair, blood, omised, pre- brackish cooked seafood
shock wound culture existing liver waters, (oysters, clams,
conditions estuaries squid, mackerel,
tuna, sardines,
crab, shrimp),
contaminated
water, open wounds.
Vibrio cholerae, toxigenic 24-72 hours (few D (profuse watery), Stool in Cary- Immunocompr Coastal, Seafood, raw or
hours to abdominal Blair, rectal swab omised, esp. brackish waters, under-cooked
5 days) cramps, N, V, dehydration, pre-existing estuaries esp. oysters,
shock liver Pacific contaminated water
conditions Northwest Recent travel to
endemic areas
Yersinia enterocolitica 3- 7 days (1-14 days) Fever, abdominal pain, D, V Stool in Cary-Blair, Children and Undercooked pork
raw stool; blood elderly more products, raw milk
susceptible
Yersinia pseudotuberculosis 3- 7 days (1-14 days) Fever, abdominal pain, D, V, Stool in Cary-Blair, Males
(can have scarlatiniform raw stool; blood
rash)
FUNGAL

Cryptococcus 2 to 14 months (C. D, abdominal cramps CSF, serum Immunocompr Pacific Inhalation
gattii) omised Northwest,
Australia, Africa

PARASITIC

Angiostrongylus cantonensis 1-3 weeks (1 day- 6 Severe HA, N, V, stiff neck, CSF, blood, serum Texas, Pacific Raw/undercooked
or A. costaricensis weeks- and other neurological Basin, SE Asia snails, slugs;
cantonensis); weeks- symptoms consistent with (A. chopped vegetables
1 meningitis (A. canontensis); cantonensis); contaminated with
year (costaricensis) Abdominal pain, fever, N, V Latin infected snails or
(A. costaricensis) slugs

68
 INVESTIGATIONS OPERATIONS MANUAL 2025 EXHIBIT 8-5

America,
Caribbean (A.
costaricencis)

Cryptosporidium 7 days (1-14 days) D (severe watery; may be Stool (2-3 Recreational water,
recurrent), samples drinking water,
abdominal cramps, N, fever collected over unpasteurized milk,
several days) contact with cattle,
children in daycare
settings (fecal-oral
transmission)
Cyclospora cayetanensis 7 days (1-14 days) D (watery), weight loss, Stool, intestinal More common Fresh fruit and
anorexia, abdominal fluid, in tropical and vegetables (e.g.,
cramps, N, V and fatigue; tissue biopsy subtropical berries, basil, snow
fever rare countries, but peas, lettuce),
occurs in contaminated water
other areas due
to contaminated
imported
produce

Entamoeba histolytica 1-4 weeks (from a few Fever, chills, lower Stool (2-3 Invasive Tropical Human reservoir,
days abdominal pain, D, bloody samples over amoebiasis countries with fecally
to several months or D (amoebic dysentery), liver several days), more common poor sanitation contaminated food
years) (or other organ) abscess blood if in young (South and or water; person-to-
disseminated adults, liver Central person less common
abscess more America, Africa,
common in and Asia)
males,
dysentery rare
before age 5
Giardia lamblia 1-3 weeks (3 days- 3 D, abdominal cramps, Stool (2-3 Drinking water,
weeks) greasy stools, gas samples recreational water,
collected over children in daycare
several days) settings (fecal-oral
transmission);
occasional food
contamination
Toxoplasma gondii 7 days (4-23 days) Cervical lymphadenopathy, Serum Raw beef
flu-like illness; if
immunocompromised,
central nervous system
(CNS) disease, myocarditis,
or pneumonitis can occur

Trichinella spiralis GI symptoms- 1-2 Muscle soreness Serum; biopsy of Consumption of raw
days; accompanied by fever tissue or undercooked
5 days- 8 weeks for and edema of eyelids meat (particularly
other are characteristic; bear, pork, wild
symptoms eosinophilia, N, V, feline, fox, dog, wolf,
chills, D, abdominal cramps, moose, horse, seal,
fatigue or walrus)
and weakness possible

VIRAL

Adenovirus 1-10 days D (prolonged), N, V, HA, Stool in Cary- Children

fever, malaise, abdominal Blair, raw stool,
pain; Types 40 and 41 can serum, naso-
cause GI outbreaks pharyngeal
swab,

69
 EXHIBIT 8-5 INVESTIGATIONS OPERATIONS MANUAL 2025

Astrovirus 1-4 days D (watery), N, V, fever, Stool in Cary- Children and Childcare facilities,
malaise, abdominal pain, Blair, raw stool, immunocompr long-term care
HA, anorexia serum omised facilities
Hepatitis A 28 days (15-50 days) Jaundice, dark urine, Stool in Cary- Men who have Foreign travel Water
fatigue, anorexia, N, D, Blair, raw stool, sex with men, contaminated
fever, HA, abdominal pain, Serum injection drug with infectious
weight loss users, human waste;
international raw, under-
adoptees cooked
mollusks
harvested from
contaminated
waters
Hepatitis E 26-42 days (15- 64 Jaundice, dark urine, D, Stool in Cary- Foreign travel, Contaminated
days) fever, abdominal pain, Blair, raw stool, especially Asia, drinking water;
arthralgia, rash, Serum Middle East, oysters,
hepatomegaly, altered Africa, and mussels, and
consciousness Central other shellfish;
America; pork, pig liver;
exposure to pigs and raw/rare
deer and boar
Norovirus 12-48 hours (10- 50 N, V, D, abdominal cramps, Stool in Cary- Institutionalize
hours) fever (low grade), HA, Blair, raw stool d populations
myalgia, malaise

Parvovirus (Human Unknown- emerging D, V, fever, abdominal pain, Stool in Cary- Children
Bocavirus, HBoV 2-4) pathogen coryza, cough Blair, raw stool,
serum, CSF
Rotavirus 1-3 days D (watery), V, fever (low Stool in Cary- Children
grade), abdominal pain Blair, raw stool
Saffold virus (SAFV) Unknown-emerging D, V, respiratory symptoms Stool in Cary- Children
pathogen (children); if invasive, then Blair, raw stool,
meningitis, encephalitis, naso- pharyngeal
myelitis, myocarditis, swab, CSF
enanthema, exanthema,
septicemia

Sapovirus 12-48 hours N, V, D, abdominal pain, Stool in Cary- Infants, young

fever, HA, myalgia Blair, raw stool children, and
institutionalize
d populations
(esp. long-
term care
facilities)

OTHER

Brainerd D agent Unknown D (Profuse, watery, Stool in Cary-

prolonged 2-36 months) Blair, raw stool
Toxins

Azaspiracid Poisoning (AZP) 12-24 hours N, V, D, abdominal cramps Shellfish, toxin Europe Mussels,
detection oysters

Carchatoxin < 1-6 hours N, V, D, and paresthesias Food Madagascar Shark,

particularly
the liver

Ciguatera toxin GI symptoms- 1-6 N, V, D, abdominal cramps, Fish for Tropical areas Predatory fish
hours (few minutes- sweating, HA, muscle aches, purification/ like barracuda,
48 hours) Neurologic paresthesia of lips, tongue, extraction and grouper, sea
symptoms- few face or extremities and mouse bioassay bass, snapper,
minutes- 48 hours temperature sensation mullet

70
 INVESTIGATIONS OPERATIONS MANUAL 2025 EXHIBIT 8-5

reversal (hot/cold sensation

flip)

Scombroid Few minutes- 3 hours Rash, D, flushing, sweating, Fish, histamine Fish such as
HA, V, burning/tingling testing tuna and
sensation in mouth, mackerel;
swelling in mouth, (bacterial
abdominal pain, and action in)
metallic taste Swiss cheese

Tetrodotoxin < 30 minutes Paresthesia of lips, Puffer fish, toxin Puffer fish
tongue, face, or testing consumption
extremities often
following
numbness; floating
sensation,
V, D, abdominal pain,
ascending paralysis,
respiratory failure

Mushroom toxin (short- Few minutes- 2 hours V, D, confusion, vision Mushrooms, Mushroom
acting) problems, salivation, toxin detection consumption
diaphoresis, hallucinations

Mushroom toxin (long- 4-24 hours D, abdominal cramps, liver Mushrooms, Mushroom
acting) and toxin detection consumption
kidney failure

Shellfish toxin (diarrheic) 30 minutes- 2 hours N, V, D, abdominal pain, Shellfish, toxin Mussels,
chills, HA, fever detection oysters,
scallops from
Gulf of Mexico,
FL

Shellfish toxin (neurotoxic) Few minutes- 3 hours Tingling and numbness of Shellfish, toxin Mussels,
lips, tongue, and throat; detection oysters,
muscle aches, dizziness and scallops from
reversal of hot/cold Gulf of Mexico,
sensation, D, V FL

Shellfish toxin (amnesic) < 24 - 48 hours V, D, abdominal pain and Shellfish, toxin Mussels,
neurologic symptoms of detection oysters,
confusion, memory loss, scallops
disorientation, seizure, or
coma

Shellfish toxin (paralytic 30 minutes- 3 hours N, V, D, paresthesia of Shellfish or water, Scallops, mussels,
poisoning) (15 mouth and lips, weakness, toxin detection clams,
minutes- 10 hours) dysphasia, dysphoria, cockles
respiratory paralysis
Chemicals

Antimony <1 hour (5 mins- 8 V, D, abdominal pain, Food or beverage Metallic container
hours) metallic taste

Arsenic Few hours N, V, D, pins and needles Urine analysis

sensation, colic
Cadmium <1 hour (5 mins- 8 N, V, D, myalgia, increased Food Seafood, oysters,
hours) salivation, abdominal pain; clams, lobsters,
often a metallic taste grains, and peanuts

Chlorinatedhydrocarbon 30 minutes- 6 hours N, V, paresthesia, dizziness, Blood, urine, stools, Storing insecticides
insecticides (aldrin, muscular weakness, gastric washings in same areas as
chlordane, DDT, endrin, anorexia, weight loss, foods; mistaking
lindane, toxaphene) confusion pesticides for
powdered foods

71
 EXHIBIT 8-5 INVESTIGATIONS OPERATIONS MANUAL 2025

Copper <1 hour (5 mins- 8 N, V (blue or green), D; Food or beverage Metallic containers
hours) often a
metallic taste
Mercury <1 week N, V, D, numbness, skin Blood, hair Fish; grains treated
rash, eye irritation, with
weakness of legs, spastic mercury containing
paralysis, impaired vision, fungicides
blindness, coma

Monosodiumglutamate Few minutes to 1 Tingling, flushing, dizziness, N/A Foods seasoned

(MSG) hour HA, N, burning sensation in with MSG
back of neck, forearms;
feeling of tightness in chest

Nicotinic acid/Niacin Few minutes to 1 Flushing, sensation of N/A Meats or other

hour warmth, itching, abdominal foods with sodium
pain, puffiness of face and nicotinate as color
knees preservative; high
doses of dietary
supplements

Nitrite poisoning 1-2 hours N, V, cyanosis/blue skin, HA, Blood, food Cured meats and
dizziness, weakness, fatigue, spinach
loss of consciousness,
chocolate-brown colored
blood

Organophosphatesor Few minutes to few N, V, abdominal pain, HA, Blood, food Spraying foods just
carbamate pesticides hours nervousness, blurred vision, before harvesting;
(Diazinon, Malathion, twitching, convulsions storing insecticides
Parathion, TEPP; Carbaryl, in same areas as
Sevin®, Lannate®, foods; mistaking
Aprocarb®) pesticides for
powdered foods

Sodium fluoride Few minutes to 2 Irritation of skin, eyes, and Vomitus, gastric Dry goods
hours respiratory tract, salty or washes, and food (powdered milk,
soapy taste in mouth, flour, baking
numbness of mouth, V, D, powder, cake mix),
dilated pupils, spasms, insecticides and
pallor, shock, collapse rodenticides
Thallium Few hours V, D, hair loss, neurologic Urine, hair Centers for
manifestations(paresthesia, Disease Control
respiratory depression, and Prevention.
bronchospasms, cranial Thallium
nerve palsies) Poisoning from
Eating
Contaminated
Cake-- Iraq, 2008.
MMWR.
September 19,
2008 / 57(37);1015-
1018.

Tin Few hours N, V, D; often a metallic Food Metallic container

taste

Triorthocresylphosphate 10 days (5-21 days) N, V, D, leg pain, ungainly N/A Using compound to
high stepping gait, food and extract foods or as
wrist drop cooking or salad oil

Zinc Few hours Stomach cramps, N, V, D, Blood, stool, saliva, Metallic container
myalgias; urine, and food
often a metallic taste

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INVESTIGATIONS OPERATIONS MANUAL 2025 EXHIBIT 8-5

Notes:
1 Unless otherwise noted, the median incubation period and range were obtained from the following three sources: Heymann, D.L.
(Ed.)(2008). Control of Communicable Diseases Manual (19th ed.). Washington, DC: American Public Health Association; Centers for
Disease Control and Prevention (CDC) (March 26, 2014) A-Z Index for Foodborne Illness. Retrieved from
[Link]
2 Victoria Lappi, John R. Archer, Elizabeth Cebelinski, Fe Leano, John M. Besser, Rachel F. Klos, Carlota Medus, Kirk E. Smith, Collette
Fitzgerald, and Jeffrey P. Davis. Foodborne Pathogens and Disease. March 2013, 10(3): 250-255. doi:10.1089/fpd.2012.1307.
3 B.R. Jackson, J. Alomia Zegarra, H. Lopez-Gatell, J. Sejvar, F. Arzate, S. Waterman, A. Sanchez Nunez, B. Lopez, J. Weiss, R. Quintero Cruz, D.
Y. Lopez Murrieta, R. Luna-Gierke, K. Heiman, A. R. Vieira, C. Fitzgerald, P. Kwan,
M. Zarate-Bermudez, D. Talkington, V. R. Hill and B. Mahon (2014). Binational outbreak of Guillain–Barré syndrome associated with
Campylobacter jejuni infection, Mexico, and USA, 2011 . Epidemiology and Infection, 142, pp 1089-1099. doi:10.1017/S0950268813001908.
§- Key epidemiological information
£- Clinical consultation and testing recommendations (including lab collection recommendations) can be obtained through
consultation with CDC.
€- Pregnant women may be more likely to present with mild, flu-like symptoms.
¥- Elderly or immunocompromised may be more likely to present with sepsis or meningitis.
N- nausea, D- diarrhea, V-vomiting, HA- headache

73
EXHIBIT 8-6 INVESTIGATIONS OPERATIONS MANUAL 2025

8-6 - VAERS Form

74
INVESTIGATIONS OPERATIONS MANUAL 2025 EXHIBIT 8-6

75
EXHIBIT 8-6 INVESTIGATIONS OPERATIONS MANUAL 2025

76
INVESTIGATIONS OPERATIONS MANUAL 2025 EXHIBIT 8-6

77
EXHIBIT 8-7 INVESTIGATIONS OPERATIONS MANUAL 2025

8-7 - MedWatch Form

78
INVESTIGATIONS OPERATIONS MANUAL 2025 EXHIBIT 8-7

79
EXHIBIT 8-7 INVESTIGATIONS OPERATIONS MANUAL 2025

80
INVESTIGATIONS OPERATIONS MANUAL 2025 EXHIBIT 8-8

8-8 -Potential Tobacco Product Violations Form

81
EXHIBIT 8-8 INVESTIGATIONS OPERATIONS MANUAL 2025

82
INVESTIGATIONS OPERATIONS MANUAL 2025 EXHIBIT 8-8

83
EXHIBIT 8-9 INVESTIGATIONS OPERATIONS MANUAL 2025

8-9 – Disaster Response Flow Diagram

84
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