FDA to Conduct Remote Importer Inspections Virtually
04.03.20
Due to COVID-19, FDA announced that it will begin conducting its inspection activities electronically for the remainder of the public health emergency.
The U.S. Food and Drug Administration announced today that it will begin requesting that importers send records required under the Foreign Supplier Verification Programs (FSVP) rule electronically or through other prompt means to the agency as it shifts to conducting these inspections remotely due to 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 means.
The travel restrictions, social distancing, and other advisories associated with COVID-19 have led to FDA’s determination that most routine onsite inspections are impractical to conduct at this time. The agency will continue remove FSVP inspections until further notice.
The limited number of remote inspections will prioritize FSVP importers of food from foreign suppliers whose onsite food facility or farm inspections have been postponed due to COVID-19. The agency is planning to continue to conduct previously assigned routine and follow-up inspections remotely during this time. Importers subject to 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 said it 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 Centers for Disease Control and Prevention.
Those that have inquiries about the temporary change in inspection protocol should submit their questions by email to FDAImportsInquiry@fda.hhs.gov
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 means.
The travel restrictions, social distancing, and other advisories associated with COVID-19 have led to FDA’s determination that most routine onsite inspections are impractical to conduct at this time. The agency will continue remove FSVP inspections until further notice.
The limited number of remote inspections will prioritize FSVP importers of food from foreign suppliers whose onsite food facility or farm inspections have been postponed due to COVID-19. The agency is planning to continue to conduct previously assigned routine and follow-up inspections remotely during this time. Importers subject to 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 said it 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 Centers for Disease Control and Prevention.
Those that have inquiries about the temporary change in inspection protocol should submit their questions by email to FDAImportsInquiry@fda.hhs.gov
