This article comes from NGFA's July 21 newsletter.
The U.S. Food and Drug Administration (FDA) on July 13 reissued two temporary guidances that have been revised to extend the enforcement discretion policies established during the COVID-19 public health emergency.
The guidances apply to supplier onsite audits for the Food Safety Modernization Act (FSMA) Preventive Controls for Human and Animal Food rules and the Foreign Supplier Verification Programs (FSVP) rule, and onsite monitoring activities and duration of already-issued certifications for the Accredited Third-Party Certification Program, when certain circumstances are met.
The enforcement discretion policies described in the revised guidances, 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 needed, the agency will publicly announce their withdrawal.
The updated guidance for the supplier onsite audits describes the following circumstances under which FDA does not intend to enforce the requirement for an onsite audit:
• The receiving facility/FSVP importer has determined an onsite audit is the appropriate verification activity; and
• The supplier due for an audit is in a region/country covered by a government travel restriction or advisory related to COVID-19; and
• Due to the travel restriction/advisory, it is temporarily impracticable for the receiving facility/FSVP importer to conduct or obtain the onsite audit; and
• The receiving facility/FSVP importer temporarily selects an alternative verification activity or activities.