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FDA Issues Draft Guidance on Refusal of Inspection by Foreign Food Establishments

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The Food and Drug Administration (FDA) recently issued Draft Guidance on its interpretation of what constitutes a refusal of inspection by a foreign food establishment or foreign government.

Though the target audience is foreign food establishments and foreign governments, the Draft Guidance provides insight into FDA’s perspective on the legal obligations that apply to all food facility inspections. In particular, FDA describes refusal to permit photography during an inspection as a refusal of inspection. We provide an overview of the Draft Guidance, including the various actions FDA considers to constitute a refusal of inspection and the repercussions when foreign food establishments or foreign governments refuse inspection. FDA requests that comments on the Draft Guidance be submitted by February 26, 2018.

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Authored by Joe Levitt, Maile Hermida, Elizabeth Fawell, and Leigh Barcham.

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