On March 17, 2020, the U.S. Food and Drug Administration (FDA) issued its “Temporary Policy Regarding Preventive Controls and FSVP [Foreign Supplier Verification Food Program] Food Supplier Verification Onsite Audit Requirements During the COVID-19 Public Health Emergency: Guidance for Industry.” As previously reported in this blog, FDA had recently announced it would postpone most foreign inspections until April 2020, cancel all foreign travel by agency officials, and limit domestic travel to “mission critical only” through April. Also as reported in this blog, FDA announced it would scale back domestic inspections in response to COVID-19.
Pursuant to the Guidance, the Agency further announces its intention to exercise enforcement discretion regarding requirements in three food regulations to conduct onsite audits of food suppliers, if other supplier verification methods are used instead: (1) Current Good Manufacturing Practices, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (21 C.F.R. part 117); (2) Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals (21 C.F.R. part 507); and Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (21 C.F.R. part 1 subpart L). The Guidance provides information regarding the specific circumstances under which FDA intends to refrain from enforcing the requirements for an onsite audit.
The Guidance notes that 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 Agency states it will provide timely notice about the withdrawal of this temporary policy. We will continue to monitor the situation for any developments.