The U.S. Food and Drug Administration has reissued two temporary guidances originally published during the COVID-19 public health emergency (PHE) for certain regulatory requirements that involve onsite visits abroad under the Food Safety Modernization Act (FSMA).
Although the PHE ended in the U.S. on May 11, 2023, FDA recognizes that certain international firms might still be impacted by COVID-19 travel restrictions and advisories. Therefore, under certain circumstances, FDA has revised two guidances to extend PHE enforcement discretion policies relative to 1) supplier onsite audits for the FSMA Preventive Controls for Human and Animal Food rules and the Foreign Supplier Verification Programs (FSVP) rule, and 2) onsite monitoring activities and duration of previously issued certifications for the Accredited Third-Party Certification Program (TPP).
The enforcement discretion policies described in the revised guidances, titled, Temporary Policy Regarding Accredited Third-Party Certification Program Onsite Observation and Certificate Duration Requirements Due to COVID-19 and Temporary Policy Regarding Preventive Controls and FSVP Food Supplier Verification Onsite Audit Requirements Due to COVID-19, remain unchanged. FDA anticipates that when the guidances are no longer required, the agency will publicly announce the withdrawal of the guidances.