FDA issued an interesting draft guidance today regarding refusing entry of food products into the United States from foreign facilities if certain circumstances are present. I have experienced many of these during my time as an FDA investigator while overseas with FDA. A link to the guidance is below.
Points of interest, based on my previous FDA experiences, include:
With warm regards,
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FDA Food Safety Modernization Act (FSMA)
What Do We Mean by ‘Refusal of Inspection’? FDA Explains
December 11, 2017
The FDA Food Safety Modernization Act (FSMA) gives the U.S. Food and Drug Administration the authority to refuse imported food admission into the United States if the agency is not permitted to inspect the foreign establishment that produced the food.
Today, the FDA issued draft guidance to explain what type of actions by a foreign food establishment or government would constitute a “refusal of inspection.” The draft guidance provides a list of examples to illustrate some of the situations that the FDA may encounter when attempting to conduct inspections.
Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government