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ICYMI: First Warning Letter Highlights Consequences of Foreign Supplier Program Violations

Friday, September 06, 2019
Sandler, Travis & Rosenberg Trade Report

The Food and Drug Administration recently issued its first warning letter to an importer concerning non-compliance with requirements under the Foreign Supplier Verification Program. Importers should take this opportunity to review these requirements, ensure they have an FSVP in place for each food they import, and conduct mock FSVP inspections to prepare for possible FDA inspections.

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, in its recent warning letter, the FDA states that an inspection of the importer’s facility found that the importer had not developed the required plan for sesame paste tahini manufactured in and imported from the West Bank.

The letter states that if the importer does not take prompt action to correct this violation the FDA may take further action. For instance, because the inspection revealed that the importer was not familiar with FSVP requirements, without corrective action the FDA may refuse admission to all food this importer imports, not just the subject tahini. The FDA could also place the importer’s food on a new import alert, which would subject it to detention without physical examination.

For more information on complying with FSVP requirements, please contact FDA Practice Leader Shelly Garg at (305) 894-1043.

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