FDA to Continue Remote FSVP Inspections in FY21, Despite Longer Time Frames

FDA will continue conducting remote inspections of importers for Foreign Supplier Verification Program compliance in fiscal year 2021, Nancy Saxenian-Emmons, an FDA supervisory consumer safety officer who leads the agency’s West Coast FSVP inspection program, said during a remote session of the Western Cargo Conference on Oct. 22.

The agency’s Division of West Coast Imports has experienced “pros and cons” with conducting remote inspections, Saxenian-Emmons said, with investigators initially raising many questions and concerns as the agency transitioned to remote inspections earlier this year due to the COVID-19 pandemic. Overall, the remote inspection program is “going well” on the West Coast after seven to eight months, with more than 90% of FDA’s FSVP inspections there being conducted virtually, she said.

FDA feels it's able to provide the same level of public health safety monitoring with remote inspections as it did with on-site inspections, with FSVP importers being held to the same standard, Saxenian-Emmons said. One benefit of remote inspections is that they allow inspectors to conduct them outside of their immediate geographical area. Inspectors also have more time to review records, and don’t feel as rushed, she said.

On the other hand, inspections are taking a lot longer to conduct, Saxenian-Emmons said. While on-site inspections took place over a period of one to three days, remote inspections can take anywhere from 10 to 15 or even 25 days, mostly due to the length of time required to exchange information, she said. Many FSVP importers aren’t as responsive because they have reduced hours and staff, and may not have personnel at the physical location of the records if they are working from home.

FDA inspectors have said they miss the face-to-face interaction of on-site inspections, Saxenian-Emmons said. Sitting around a conference room table and exchanging information face-to-face means they’re better able to tell whether the importer understands the back-and-forth, she said.