Hot off the press is FDA’s newly issued industry guidance, issued today, October 20, that details actions, statements and conduct by a foreign food establishment or foreign government that FDA considers to constitute a refusal of an FDA inspection. See new guidance here. FDA explains in the guidance that the Agency considers refusal to permit scheduling of an inspection, refusal to permit FDA from conducting an inspection, and interfering or causing delay with an inspection, as factors which FDA would use to determine a foreign establishment or government’s refusal of an FDA inspection.
As U.S. imported food comes from around the world, FDA helps ensure that imported foods are safe and compliant with U.S. law by conducting foreign food facility inspections to identify potential food safety and quality concerns. Under the Food Safety Modernization Act (FSMA), FDA has authority to refuse entry of food offered for U.S. import if the foreign food establishment or foreign government has refused FDA to inspect the foreign establishment that produced the food.
What has always remained an issue is the ability of an investigator to take photographs. Interestingly, FDA has called out a facility’s refusal of permitting an investigator to take photographs as constituting a refusal of an inspection.
Companies are reminded to understand FDA inspection protocols, ensure that their conduct and representations do not limit an FDA investigator’s ability to conduct an inspection, and be prepared for unannounced FDA inspections!
Please feel free to contact us to understand the implications of FDA’s new guidance document, to assist with an FDA inspection or to respond to Inspectional Observations.
