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Guidelines for Proposing Import Alerts

New import alerts can be proposed by various FDA units and must have management concurrence. Recommendations should be submitted to OIO and include the purpose, background information, national significance, volume of entries, and a complete product description. This ensures that all relevant details are considered for the import alert process.

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5 views1 page

Guidelines for Proposing Import Alerts

New import alerts can be proposed by various FDA units and must have management concurrence. Recommendations should be submitted to OIO and include the purpose, background information, national significance, volume of entries, and a complete product description. This ensures that all relevant details are considered for the import alert process.

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cqa
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© All Rights Reserved
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Initiating an Import Alert

New import alerts may be proposed by ORA units or offices, the centers, or any FDA unit. Recommendations for
import alerts should have the concurrence of the appropriate management of the requesting unit.

Submit recommendations for import alerts to OIO. Include the following information in the recommendation
memorandum:

• Purpose of the import alert.

• All pertinent background information such as sample results, violation rates or trends, etc.

• The national significance of the problem (health hazard, etc.).

• The volume of entries, number of importers, foreign shippers, countries involved, other product information
such as whether it is seasonal in nature, etc.

• An accurate and complete description of the product, including its packaging and how it is to be stored.

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