Regulatory Watch

FDA issues guidance for refused inspections

Guidance explains how FDA interprets refusals of entry for inspection

The FDA has issued guidance for how it interprets refusals of entry for inspection for foreign food facilities as well as foreign governments.

The FDA’s Import Alert 99-32 has a red list of foreign establishments of which the owner, operator, agent in charge or foreign government has refused an inspection. Food offered from these establishments is subject to refusal of admission.

In the cases of government refusals, establishments will be added to the red list on a case-by-case basis, but if refusals are sustained, FDA will ask the foreign government if refusal applies to all establishments in the country. If so, all establishments in the country will be added to the red list.

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Casey Laughman is the former Editor in Chief of Food Engineering magazine. He has almost two decades’ experience as a writer and editor for mainstream and trade publications. He spent several years as a writer and editor for two news services before becoming the editor of a legal publication and managing editor of a trade magazine that covered the commercial facilities market.