Background

The Food and Drug Administration continues to issue warning letters to importers concerning noncompliance with requirements under the Foreign Supplier Verification Program, which 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.

Most recently, FDA inspections of the facilities of two importers found that they failed to develop, maintain, and follow FSVPs with respect to imported eggplant, seaweed, chestnuts, gelatin, rice flours, crackers, rice snacks, fruit preserves, green tea, dried bamboo leaf, mushrooms, and candy.

In addition, the FDA determined that one importer did not evaluate its foreign supplier’s performance and the risk posed by the food, document its approval of the foreign supplier on the basis of the evaluation, or conduct an analysis to determine whether there are any hazards requiring a control.

The FDA states that within 15 working days the importers should provide information on the specific things they are doing to correct these violations; e.g., 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, such as refusing admission of violative products and subjecting the importer to detention without physical examination.

For more information on these and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939 or via email.

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