FDA will begin tougher enforcement of FSVP requirements.

We recently participated in a conference call with FDA representatives in attendance. During this meeting it was made clear that the FDA would be increasing both remote, and on-site inspections, and reviews of compliance with the FSVP program. Based on their recent experience with FSVP enforcement, the FDA anticipates it will be issuing more warning letters to Importers for FSVP failures. The warning letters are posted on the FDA website, several examples are currently there for review.  

This link will bring you to the FDA document that outlines the FSVP Regulation records requirements.

An additional step the FDA is taking to ensure food safety is to isolate any repeat violations. The U.S. Importer and the food item that are cited for repeat violations that are not addressed or brought in to compliance can be placed on Import Alert.  Once placed on Import Alert shipments coming in to the U.S. are placed on immediate hold and are not allowed to enter the commerce of the United States.  

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