Background

The Food and Drug Administration recently issued warning letters to two importers concerning noncompliance with requirements under the Foreign Supplier Verification Program.

The FSVP requires importers to perform certain risk-based activities to verify that the human and/or animal food they import has been produced in a manner that meets applicable U.S. food safety standards. However, the FDA states that an inspection of these importers’ facilities found that the importers did not have the required plan for food products they import.

The letters state that the importers should provide within 15 working days information on the specific things they are doing to correct these violations, including documentation of changes made and records to demonstrate implementation of an FSVP. If the importers do not act promptly the FDA may take further action; e.g., refusing admission of the violative products or subjecting them to detention without physical examination.

For more information on the FSVP, please contact FDA consultant Domenic Veneziano at (202) 734-3939.

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