CFSAN Constituent Update - What Do We Mean by "Refusal of Inspection"? FDA Explains

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.

So in FDA’s eyes, what actions by a foreign food establishment or government constitute a “refusal of inspection”?  Today, the agency issued a draft guidance to address that question.

Food for sale in the United States comes from all over the world. Inspections are an important tool the FDA uses to protect our food supply. The FDA conducts inspections of foreign food facilities to identify potential food safety concerns before food products reach our shores, but sometimes foreign food establishments or governments won’t permit the FDA to enter the facility and inspect. Under FSMA, FDA now has the authority to refuse entry of food from such establishments.

FDA’s draft guidance recognizes that not all “refusals” come as direct statements.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. This draft guidance provides a list of examples to illustrate some of the situations that the FDA may encounter when attempting to conduct inspections.

The draft guidance will be available for public comment for 75 days from its date of publication in the Federal Register. The FDA will consider all comments before completing a final version. Comments should be submitted to http://www.regulations.gov and identified with the docket number listed in the notice of availability that publishes in the Federal Register.

For More Information

Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government