FDA announces expanded use of unannounced inspections at foreign manufacturing facilities

Although FDA is not required by the Federal Food, Drug, and Cosmetic Act or its own regulations to give foreign manufacturers advance notice of regulatory inspections, this has long been the agency’s standard practice.²  The change in agency policy builds on FDA’s existing Unannounced Inspection Pilot Program currently in place for human drug manufacturers operating in India and China.  In addition to expanding the use of unannounced inspections for foreign facilities, the announcement said that FDA would be “clarifying policies for FDA investigators to refuse travel accommodations from regulated industry including lodging and transportation arrangements . . . , to maintain the integrity of the inspection oversight process.”

Of note, foreign facilities are subject to additional conditions not imposed on domestic facilities if they refuse an inspection.  FDA has issued guidance outlining the consequences for foreign manufacturers who refuse a FDA inspection.³  This guidance explains that foods produced at facilities that have refused inspection will not be allowed to be sold in the United States.  This refusal could take various forms, including placing the facility on Import Alert, increasing the sampling or examination of products from the facility, refusal of admission, or other regulatory, judicial, and administrative measures.⁴

Why it matters

There are many unanswered questions about this announcement, including whether FDA will continue its longstanding practice of coordinating foreign inspections with foreign authorities. Historically, before initiating a foreign facility inspection FDA has sent an advance notification to the Competent Authority responsible for food safety in the country where FDA will be conducting an inspection.  It also shares the inspection itinerary once the inspection is planned.  FDA also has always welcomed the Competent Authority to observe FDA inspections conducted in the country.  It is unclear whether these practices will continue.

Additionally, it is unclear whether this shift toward unannounced foreign inspections could result in an increase in the number of foreign inspections conducted each year.  FDA has been criticized for years, including in a recent Government Accountability Office (GAO) report, for failing to meet its foreign food facility inspection mandates.⁵  For example, the FDA Food Safety Modernization Act (FSMA) requires FDA to conduct 19,200 foreign food facility inspections annually, but in FY 2019 the agency conducted only 1,727 foreign food facility inspections, the most completed in any year, which is still only 9% of the annual statutory requirement.  Further, there are questions about whether an expansion in foreign unannounced inspections is truly feasible under the agency’s current resource and staffing levels given the recent significant changes to personnel at the agency.

Next steps

Companies with foreign food facilities should ensure all sites are inspection ready every day and should consider conducting mock FDA inspections to prepare their teams for how to handle an unannounced inspection.   If FDA arrives to inspect, foreign facilities would be well served to quickly engage FDA food regulatory counsel to advise in real time during the inspection, particularly with respect to potential allegations of refusal of inspection.  It also will be important to promptly and thoroughly respond to any FDA Form 483 inspectional observations issued during these inspections, given the significant impacts that can ensue from a poor inspection result. 

Authored by Elizabeth Fawell, Maile Gradison, and Erin Pannek.