Limited Foreign Supplier Verification Inspections Continue Through Remote Document Review During COVID-19

On April 3, 2020, the Food and Drug Administration (FDA) issued a Constituent Update notifying the public that for Foreign Supplier Verification Program (FSVP) inspections, FDA requests importers electronically send records to FDA for review. This is a temporary policy shift in response to COVID-19. Typically, FDA conducts routine, on-site FSVP inspections, which include documentation review to ensure that importers of record are taking necessary steps to verify that foreign foods they are importing are grown/manufactured in compliance with FSMA regulations. Now, FDA is requesting that FSVP records be sent remotely to FDA for review. This is an important departure from FDA’s ordinary practices, as FDA does not always take copies of records into its possession during routine inspections. With copies of importer records being sent directly to FDA, it is important that these records are clearly marked “confidential” to avoid potential public disclosure through FOIA requests.

Which FSVP Inspections Is FDA Prioritizing?

FDA will immediately begin conducting a limited number of FSVP inspections, including previously assigned routine and follow-up inspections. FDA is prioritizing inspections of FSVP importers who are importing food from foreign facilities and farms whose onsite FSMA inspections have been postponed due to the pandemic. FDA is still conducting in-person FSVP inspections in response to foodborne-illness outbreaks. Importers of record are encouraged to keep their FSVP documentation up to date as FDA is using FSVP inspections as a stopgap to fill in for stalled foreign facility and grower inspections due to COVID-19.

As the number of cases around the world grows, Faegre Drinker’s Coronavirus Resource Center is available to help you understand and assess the legal, regulatory and commercial implications of COVID-19.