FDA lists enforcement actions if foreign inspection denied

The Food and Drug Administration has issued a document explaining its enforcement actions if a foreign food company or a foreign government refuses to allow a FDA inspection.

The 12-page document states the Food Safety Modernization Act gives the agency the authority to refuse food imports from a foreign company if that company or its government refuses to allow an FDA food safety inspection.

The draft guidance, according to a news release, outlines what actions represent a “refusal of inspection” and what consequences there could be.

According to the release, not all “refusals” come as direct statements. The FDA also defines refusals as passive or deceptive tactics employed by foreign entities to “delay or avoid inspections or to mislead FDA investigators,” according to the release.

The draft guidance is available for 75 days for comment at http://www.regulations.gov and the agency will consider all comments before issuing a final decision, according to the release.
 

 

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