FDA Foreign Supplier Program Violations

FDA Foreign Supplier Program Violations

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Foreign Supplier Program Violations
The FDA 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 one importer found that it failed to develop, maintain, and follow an FSVP for fresh enoki mushrooms. The FDA has given the importer 15 working days to provide information on the specific things it is doing to correct this violation; 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 violative products and subjecting the importer to detention without physical examination.

The FDA notes that the mushrooms at issue have already been placed under two import alerts and that this information should be taken into consideration when the importer evaluates its suppliers and develops its FSVP.

Import Alerts: Cookware, Medical Instruments, Seafood, Produce
FDA import alerts affecting the following have been newly issued or modified in the past week.

• breads and baked goods from China
• cantaloupes from Mexico
• cassava from Thailand
• cookware from China
• drugs from Switzerland
• enoki mushrooms from China and Korea
• green onion from Mexico
• hair oil from India
• medical instruments from Pakistan
• melon from Nigeria
• pompano from China
• quinoa seed from India
• radish from Mexico
• tamarind beverage from Mexico
• uneviscerated or partially eviscerated fish from Sri Lanka

Import alerts inform FDA field staff that the agency has enough evidence or other information to allow a product that appears to be in violation of FDA laws and regulations to be detained without physical examination at the time of entry. Import alerts may cover products from designated countries or areas (including from all foreign countries), manufacturers, or shippers.

Firms and/or products on the “red list” of an import alert are subject to Detention without Physical Exam (DWPE), while firms and/or products on the “green list” are not because they have met the criteria for exclusion. Some import alerts include a “yellow list” of firms, products, and/or countries subject to intensified surveillance because the nature of the violations may warrant further field examinations of individual entries and/or additional analyses. In addition, depending on the specific import alert, shipments of products subject to DWPE may still be imported into the U.S. if the importer has demonstrated that the shipment is in compliance.

If a product is detained without physical examination the importer has the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If no such evidence is submitted, or if the evidence provided is insufficient, the product will be subject to refusal of entry into the U.S.

Please contact your Western Overseas representative with any questions.