What FDA Means by Refusal of Inspection

What FDA Means by Refusal of Inspection

FDA publishes draft guidance on actions by a foreign food establishment or government that constitute a “refusal of inspection.”

December 12, 2017

The Food Safety Modernization Act (FSMA) gives FDA 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.

To address the question of what FDA considers to be actions by a foreign food establishment or government constitute a “refusal of inspection,” the agency has issued a draft guidance.

With food for sale in the United States coming from all over the world, FDA sees inspections are an important tool to protect our food supply. 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 agency 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FDA’s draft guidance recognizes that not all “refusals” come as direct statements.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 This draft guidance provides a list of examples to illustrate some of the situations that the FDA may encounter when attempting to conduct inspections.

The draft guidance will be available for public comment for 75 days from December 12, 2017, its date of publication in the Federal Register.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For more information see Draft Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government