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FDA Resumes Records Review Under the FSVP Rule by Remote Inspections Instead of Onsite Visits to Importers

The Food Safety Modernization Act’s (FSMA) Foreign Supplier Verification Program (FSVP) requires importers to perform certain risk-based activities to verify that their foreign supplier is producing food in accordance with U.S. food safety standards.  Inspections by the Food and Drug Administration (FDA) to review FSVP records are typically conducted at an importer’s place of business.

As previously reported on this blog, FDA announced a temporary halt of all domestic routine surveillance facility inspections on March 18, 2020 due to the COVID-19 public health emergency.  This followed the March 17, 2020 announcement, discussed here, of FDA’s temporary enforcement discretion policy regarding requirements for the importer to conduct onsite audits of food suppliers.

On April 3, 2020, FDA announced that it will temporarily conduct remote inspections under the FSVP, beginning with previously assigned routine and follow-up inspections falling in April as well as previously scheduled inspections that had been postponed due to COVID-19.  Importers subject to the remote inspections will be contacted by an FDA investigator who will explain the process for the remote inspection and make a written request for records.  FDA reserves the option to conduct an onsite FSVP inspection in response to an outbreak of foodborne illness or where otherwise warranted.

FDA will continue to conduct FSVP inspections of importers’ records remotely until further notice and importers may continue to use others means of supplier verification in lieu of onsite audits until a reasonable time after social distancing recommendations and COVID-19 travel advisories are lifted.  Additionally, in another adjustment to the corona virus outbreak, FDA announced on April 3, 2020 a further extension of the comment period for the proposed rule to establish a laboratory accreditation program for the testing of human and animal food in certain circumstances by accredited laboratories.  See our previous blog on the laboratory accreditation program.

© 2020 Keller and Heckman LLP

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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