Background

The Food and Drug Administration 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.

Violations. Most recently, FDA inspections of the facilities of three importers found that they failed to do one or more of the following respect to imported tamarind paste, roasted foxnuts, mango pulp, curried mustard leaves, chocolate bar, chocolate dairy mix, botanas puffed snack, guava paste, coconut water with pulp, and frozen yellow pepper dices.

- 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

- provide documentation that the foreign supplier’s hazard analysis was reviewed and assessed

- approve foreign suppliers on the basis of an evaluation of their performance and the risk posed by the food

- establish and follow written procedures to ensure only foods from approved foreign suppliers are imported

- establish written procedures for ensuring that appropriate foreign supplier verification activities are conducted

- conduct and document one or more supplier verification activities before importing the food

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.

Guidance. In relation to these violations, the FDA notes that one of the importers did not maintain its own records of its imported foods and instead only requested documents as needed from its foreign suppliers but did not review those documents.

The FDA also points out that the foreign supplier for purposes of the FSVP regulation might not be the entity from which the importer directly obtains the food. If food is obtained from a foreign warehouse, distributor, broker, or other entity that does not perform any manufacturing or processing of a more-than-de minimis nature, the foreign supplier of the food would be the last entity in the foreign supply chain that conducts significant manufacturing or processing. Importers are responsible for evaluating and approving such foreign suppliers and determining and conducting appropriate verification activities. 

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

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