Background

The Food and Drug Administration has published on its website a final guidance providing information on when the FDA may consider that a foreign food establishment subject to FDA inspection or a foreign government has refused to permit an FDA inspection.

The Federal Food, Drug, and Cosmetic Act requires the FDA to refuse admission into the U.S. of a food from a foreign food establishment of which the owner, operator, or agent in charge, or the foreign government, refuses to permit an inspection. As a result, foreign food establishments that have refused an FDA inspection will be identified on the “Red List” of Import Alert 99-32 and food offered by such establishments for entry into the U.S. will be refused admission.

According to the new guidance, the FDA considers inspection refusals to include statements, actions, and passive behaviors that (1) prevent or delay it from scheduling or fully conducting an inspection or (2) are intended to avoid inspection or to mislead or deceive FDA investigators in a manner that prevents them from conducting the inspection. The guidance provides examples of situations the FDA may consider to be a refusal, though these examples are not intended to serve as an exhaustive list.

This guidance finalizes a draft version issued in December 2017 with several changes, including providing additional information on the FDA’s inspection authority; clarifying that the investigator will inform the owner, operator, or agent in charge of the establishment when they consider their action to be a refusal and will explain the consequences of the refusal; and clarifying that the FDA will make the final decision regarding refusal and listing on Import Alert 99-32.

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