Background

Foreign Supplier Program Violations

The Food and Drug Administration continues to issue warning letters to importers 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.

In the latest case, two FDA inspections of the importer’s facility found that the importer did not have the required plans for fried onions, basmati rice, and other products. The FDA 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 and subjecting them to detention without physical examination.

For more information on the FSVP, please contact FDA consultant Domenic Veneziano at (202) 734-3939.

Import Alerts on Foods, Drugs, and Medical Devices That May be Detained

Food and Drug Administration import alerts on the following have been modified in the past week.

- spices and spice products

- dietary supplement products from firms that have not met dietary supplement good manufacturing practices

- products from firms refusing FDA foreign establishment inspection

- ceramicware

- dried fungus (mushrooms) from Hong Kong and China

- shrimp

- vegetable protein products from China for animal or human food use

- foods containing illegal and/or undeclared colors

- fruit juices and fruit juice concentrates

- low-acid canned foods or acidified foods

For more information on import alerts and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939.

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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