FDA Continues FSVP Enforcement Via Remote Inspections During COVID-19 Pandemic

FDA continues its enforcement of Foreign Supplier Verification Program requirements, even amid the halt to on-site importer inspections that began in late March as a result of the COVID-19 pandemic. The agency has conducted more than 290 remote FSVP inspections since the pandemic suppression measures began, and has issued 19 warning letters to FSVP importers found not to be in compliance with FSVP provisions, an FDA spokesperson emailed.

“Due to the government orders and advisories associated with the COVID-19 Pandemic, the FDA has determined that most routine onsite inspections should be rescheduled or approached using remote protocols,” the spokesperson said. “Remote protocols have verification steps that help FDA investigators determine whether a firm is in compliance. Therefore, the Agency has shifted to conducting FSVP inspections remotely until inspections can resume following White House Guidelines for Opening Up America Again,” he said.

FDA is prioritizing remote assessments of FSVP importers that import food from foreign suppliers whose on-site food facility or farm inspections have been postponed due to COVID-19, the spokesperson said. The agency issued a guidance document in March temporarily loosening requirements for on-site supplier audit requirements required by FSVP and FDA’s preventive controls regulations in countries with travel restrictions imposed as a result of the pandemic (see 2003180049).

If FDA decides to conduct a remote inspection, its investigator will telephone the FSVP importer. “The investigator will educate the importer on the regulations and guidance, explain the process for the remote inspection, and subsequently issue an official written request for records via email,” the spokesperson said. “Upon receipt of the requested records, FDA will evaluate importer’s FSVP and then share our findings, ask any clarifying questions, request additional information, and/or close-out the inspection, as appropriate. All of this is accomplished via email and/or phone call.”

Recent months have seen an uptick in FDA warning letters to importers for FSVP regulations, the FDA’s online warning letter database showed. The agency posted 12 letters issued in April and May -- seven and five, respectively -- which is more than double the maximum of five warning letters FDA had issued in any previous two-month stretch. Prior to April’s seven FSVP warning letters, the most FDA had issued to importers in any month was three in December 2019. The Division of Northeast Imports was particularly active in April and May, issuing six of the 12 total issued by FDA in those two months.

FDA has as of press time posted only one warning letter for June, but generally weeks to months pass between the date FDA issues a warning letter and the date it is posted to the agency’s website. All the inspections that resulted in the warning letters posted by FDA so far were conducted during the first week of March or earlier, before the agency shifted to remote importer inspections.