For more information on these and other Food and Drug Administration issues, please contact Domenic Veneziano at (202) 734-3939.
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 two importers found that they failed to do one or more of the following respect to imported Napa cabbage kimchi, soybean paste, black coffee, green tea, and Kona coffee.
- develop, maintain, and follow an FSVP
- verify and document that thermally-processed low-acid foods packaged in hermetically sealed containers were produced in accordance with applicable requirements
The FDA states that within 15 working days these 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 them to detention without physical examination.
The FDA also advised one of the importers to (1) establish and follow written procedures to ensure it imports foods only from foreign suppliers it has approved based on an evaluation of the supplier’s performance and the risk posed by the food and (2) update its FSVP if it has determined that an onsite audit by a qualified auditor is an appropriate foreign supplier verification activity for its foreign supplier.
FDA import alerts affecting the following have been newly issued or modified in the past week.
- medical instruments from Pakistan
- antibiotics from India
- pharmaceutical necessities and containers for drugs from Italy, the Netherlands, New Zealand, Singapore, South Africa, and the United Kingdom
- UV germicidal lamps from China
- antifungal cream from India
- cotija cheese from Mexico
- shrimp from Bangladesh, Indonesia, and Thailand
Importers of FDA-regulated goods are responsible for ensuring that such imports are in compliance with FDA laws and regulations. Before shipping into the U.S., importers should be aware of whether or not their product is listed on an import alert.
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 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.
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