FDA Issues Updated Facility Inspection Report


By: Fran Kritz

June 3, 2021

Categories: AAMI News, Medical Device Manufacturers

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The Food and Drug Administration (FDA) recently issued a new report, Resiliency Roadmap for FDA Inspectional Oversight, to outline its plans for inspecting facilities it oversees in the months ahead.

In March 2020, as cases of COVID-19 increased in the U.S., the FDA announced that it was temporarily postponing all domestic and foreign routine surveillance facility inspections, though the agency continued “mission critical” inspections when possible. Such inspections were done when possible, for example, in cases of drug shortages, for approval of novel drugs or drugs related to COVID-19 and to support of premarket and prelicense applications.  

“Like most organizations around the world, the FDA experienced unprecedented and unique challenges during the SARS-CoV-2 pandemic, said Acting FDA Commissioner Janet Woodcock, M.D. “In particular,” said Woodcock, “our inspection, surveillance and compliance activities were significantly impacted. The FDA fully understands the importance of getting back to a more consistent state of inspectional capacity. This plan provides…a transparent picture of both the successes and challenges we’ve faced in these areas over the past year, as well as our plan moving forward.”

The FDA began resuming prioritized domestic inspections  in July 2020 using the agency’s COVID-19 Advisory Rating system.

The new report includes information on inspections the agency was unable to complete during the past year due to travel restrictions or inability to ensure the safety of workers.

Key facts from the report:

  • From March 2020 through March 2021, the FDA conducted a total of 821 mission-critical inspections, including 29 in foreign countries.

  • The FDA conducted a total of 777 prioritized domestic inspections since resumption of that work in July 2020.

  • The FDA used alternative tools and approaches where inspections weren’t possible including remote interactive evaluations (remote livestreaming video of operations, teleconferences or screen sharing) and records requests. 

Looking ahead, the agency says that in the short term “inspections considered critical to the FDA’s mission will remain the primary focus and that when planning routine surveillance inspections, the FDA will be prioritizing  higher-risk facilities which means there may be a longer time between inspections for lower risk facilities “as the FDA adjusts to the impact of the COVID-19 pandemic.”

The agency will also soon begin a review of inspection approaches using next-generation assessment technologies and improvements. The FDA is also establishing an agency-wide FDA Inspectional Affairs Council that will plan and coordinate inspection activities.