FDA pauses routine onsite inspections under foreign supplier verification program

FDA announced Friday it will refrain from most routine inspections of importers under a rule aimed to ensure importers are conducting certain risk-based activities to confirm foreign suppliers produce food based on U.S. safety standards.

Instead, FDA will conduct “inspections remotely during the COVID-19 public health emergency” by requesting food importers deliver certain records to the agency “electronically or through other prompt means,” according to an FDA constituent update.

The records are required under the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP). FDA adopted the comprehensive regulation in 2015 under the FDA Food Safety Modernization Act (FSMA).

“Until now, FSVP inspections to review FSVP records typically have been conducted at an importer’s place of business,” the agency explained in the constituent update. “However, under the FSVP regulation, FDA has the authority to make written requests for importers to provide records to the agency electronically or by other prompt means. Because of the travel restrictions, social distancing and other advisories associated with the COVID-19 outbreak, the FDA has determined that most routine onsite inspections are temporarily impractical to conduct at this time.”

Until further notice, FDA plans to shift to remote FSVP inspections. An FDA investigator will contact importers who are subject to a remote inspection, explaining the process and requesting written records, the agency said.

FDA cautioned it may decide to inspect a facility onsite in “rare situations, such as in response to an outbreak of foodborne illness,” in which case an FDA investigator will perform an inspection while following social distancing recommendations from the Centers for Disease Control and Prevention (CDC).

FDA encouraged people with questions about the temporary change in its inspection protocol to submit their questions online to [email protected].

In March, the agency announced it was postponing routine domestic facility inspections as it strived to protect its staff and contract workers amid COVID-19. In a statement, FDA Commissioner Stephen Hahn, M.D., said his agency will move forward with “for-cause inspection assignments” if they are deemed “mission-critical,” such as an outbreak or natural disaster. FDA previously announced it was postponing most foreign facility inspections through April, though it would evaluate “inspections outside the U.S. deemed mission-critical.”