Background

The Food and Drug Administration recently issued a warning letter to an importer 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 this importer’s facility found that the importer did not have the required plans for dry food products imported from Turkey and other sources.

In addition, the FDA notes that (a) this was the second time it found an FSVP violation by this importer and (b) the importer said it would look for a consultant to help it with FSVP compliance but has given no indication that it actually engaged a consultant or is otherwise in compliance with FSVP requirements.

The letter states that within 15 working days the importer should provide information on the specific things it is doing to correct these violations; e.g., documentation of changes made and records to demonstrate implementation of an FSVP. If the importer does not act promptly the FDA may take further action, such as refusing admission of the violative products, including 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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