Background

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 one importer found the following significant violations with respect to pecorino cheese: (1) failure to review and assess foreign supplier’s hazard analysis, (2) failure to approve foreign suppliers based on evaluation of their performance and risk posed by food, (3) failure to establish and follow written procedures to ensure food is only imported from approved foreign suppliers, (4) failure to establish and follow adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to imported food, (5) failure to reevaluate foreign supplier’s performance and risk when new information about risk factors became known, and (6) failure to take appropriate corrective action when verification provided insufficient assurance of hazard minimization or prevention.

FDA inspections of another importer found that it (1) did not develop, maintain, and follow the required plans for canned corn, mushrooms, and bamboo and (2) failed to verify and document that these thermally-processed low-acid foods were packaged in hermetically sealed containers.

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.

Cosmetics, Seafood, Candy, Medical Items Among Modified Import Alerts

FDA import alerts affecting the following have been modified in the past week.

- cosmetics from China

- antibiotics from China

- sesame seed from Syria

- candy from Syria

- raw and cooked shrimp from India

- croaker from China

- mangosteen juice from the United Kingdom

- dietary supplements from the United Kingdom
- bamboo shoots from China

- surgeon’s and patient examination gloves

- medical instruments from Pakistan

- cosmetics

- tamarind products (fresh and/or processed) from all shippers from all countries

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.

Copyright © 2020 Sandler, Travis & Rosenberg, P.A.; WorldTrade Interactive, Inc. All rights reserved.

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