FDA issues report detailing inspection activity during COVID-19 pandemic

By David Fairfield, Senior Vice President, Feed

The U.S. Food and Drug Administration (FDA) today issued a report titled, “Resiliency Roadmap for FDA Inspectional Oversight,” outlining the agency’s inspectional activities during the COVID-19 pandemic and its plan for future inspections.

In March 2020, FDA announced that it was temporarily postponing all domestic and foreign routine surveillance facility inspections, while continuing mission-critical inspections when possible. Beginning the week of July 20, 2020, FDA began to work toward resuming prioritized domestic inspections using its COVID-19 Advisory Rating system. The report outlines inspections that the agency was unable to complete during the past year due to the pandemic, as well as the number of mission-critical inspections completed, such as inspections conducted in response to foodborne disease outbreaks or other food safety risks.

Highlights from the report related to animal food include:

• From March 2020 through March 2021,
  • FDA investigators conducted 26 mission-critical animal food inspections.
  • FDA investigators conducted 17 animal food inspections after resuming prioritized domestic inspections in July 2020.
  • FDA’s state partners conducted 1,295 animal food inspections on behalf of FDA.
  • FDA conducted 1,183 remote Foreign Supplier Verification Program (FSVP) inspections (FDA’s FSVP rule provides FDA remote inspectional authority to evaluate compliance with the regulations).

• FDA’s fiscal year (FY) 2021 plan calls for 1,705 additional animal food surveillance inspections to occur by Sept. 30, 2021 (FDA’s routine surveillance inspections are conducted to assess facility operations and are planned by applying established risk factors and statutory frequency mandates).
• FDA expects that 85 percent of FY 2021 surveillance inspections at animal food facilities will be conducted under contract by state partners.
• For remaining FY 2021 domestic human and animal food surveillance inspections scheduled to be conducted by FDA investigators (not state partners), FDA estimates under best-case scenarios that completing between 10 to 21 percent of such inspections is achievable (the report does not provide estimates specific to animal food).
• When planning routine surveillance inspections, FDA prioritizes higher-risk establishments. Therefore, a longer interval between inspections will occur for facilities not characterized as “higher-risk” as FDA adjusts to the impact of the COVID-19 pandemic. FDA’s recently released Comprehensive Animal Food Inspection Compliance Program Guidance Manual details how FDA selects high and low regulatory priority animal food facilities.