FDA Issues Final Guidance on Refusal of Inspection by a Foreign Food Establishment or Foreign Government

Constituent Update

October 20, 2022

Today, the U.S. Food and Drug Administration (FDA) issued guidance that describes the actions, behaviors, and statements by a foreign food establishment or foreign government that the FDA considers to be a refusal of an FDA inspection.

Food for importation into the United States comes from all over the world.  One way that the FDA protects the U.S. food supply is by conducting inspections of foreign food facilities to identify potential food safety concerns. 

The FDA Food Safety Modernization Act (FSMA) gives the FDA authority to refuse entry of food offered for importation into the United States if the foreign food establishment or foreign government has refused to permit the FDA to inspect the foreign establishment that produced the food. The guidance issued today provides examples of situations that FDA may consider as constituting refusal.

For More Information

• Guidance for Industry: Refusal of Inspection by a Foreign Food Establishment or Foreign Government
• Federal Register Notice