FDA to Temporarily Conduct Remote Importer Inspections under FSVP Due to COVID-19
The U.S. Food and Drug Administration (FDA) announced last week that it will begin requesting that importers send records required under the Foreign Supplier Verification Program (FSVP) for Importers of Food for Humans and Animals FSVP rule electronically (or through other prompt means) to the agency as it shifts to conducting these inspections remotely during the COVID-19 public health emergency.
The FSVP rule requires importers to perform certain risk-based activities to verify that their foreign supplier is producing the food in accordance with U.S. food safety standards. Until now, FSVP inspections to review FSVP records typically have been conducted at an importer’s place of business. 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. Therefore, the agency will shift to temporarily conducting FSVP inspections remotely as practical until further notice.
The FDA will immediately begin conducting a limited number of remote inspections, prioritizing the inspections of FSVP importers of food from foreign suppliers whose onsite food facility or farm inspections have been postponed due to COVID-19. The agency is also planning to continue to conduct previously assigned routine and follow-up inspections remotely during this time. Importers subject to the remote inspections will be contacted by an FDA investigator who will explain the process for the remote inspection and make written requests for records.
In rare situations, such as in response to an outbreak of foodborne illness, FDA may still choose to conduct an onsite FSVP inspection. In these instances, an FDA investigator will make arrangements to conduct the inspection while practicing the social distancing recommendations provided by the U.S. Centers for Disease Control and Prevention.
Those that have questions about this temporary change in inspection protocol are encouraged to submit their questions online to FDAImportsInquiry@fda.hhs.gov.