FDA Extends Two COVID-19 Temporary Guidances Related to Onsite Visits Abroad Under FSMA
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).