FDA Extends COVID-19 Policy Allowing Alternatives to FSVP On-Site Audits
FDA will continue its policy of not requiring on-site audits for importers under the agency’s preventive controls and Foreign Supplier Verification Program regulations where COVID-19 travel advisories make them impractical until further notice, despite the recent end to the government’s public health emergency in May, the agency said in a revised guidance document released July 13.
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First issued in March 2020 (see 2003180049), the guidance said FDA will not enforce on-site audit requirements in countries where travel advisories or restrictions due to COVID-19 make it impossible to conduct the on-site audit, as long as an alternative verification activity is selected. Under FSVP and the preventive control rules, importers may conduct audits of supplier verification activities, and on-site audits are the preferred verification activity when the supplier controls a hazard that risks serious health consequences or death.
Though the public health emergency ended, “FDA recognizes that certain international firms might still be impacted by COVID-19 travel restrictions and advisories,” the agency said in a constituent update.
FDA said in the guidance that it “intends to provide timely notice” of the eventual “withdrawal” of the enforcement discretion policy. In the meantime, “receiving facilities and FSVP importers should resume onsite audits within a reasonable period of time after it becomes practicable to do so, and should update their food safety plans and foreign supplier verification programs accordingly,” the guidance said.