Foreign Supplier Program Violation Gets FDA Warning
© , Sandler, Travis & Rosenberg, P.A. Originally published in the [02/20/2020] issue of the Sandler, Travis & Rosenberg Trade Report. Reprinted by permission.
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 plan for its black tea.
In addition, the FDA notes that while the importer provided a copy of the hazard analysis included in its foreign supplier’s hazard analysis and critical control point plan for black tea, that analysis was insufficient and the importer does not appear to have conducted its own review and assessment of it.
The letter states that within 15 working days the importer should provide information on the specific things it is doing to correct these violations, including 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; e.g., 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.