FDA Outlines Inspection and Assessment Activities During Pandemic, Roadmap for Future State of Operations

On 5 May 2021 the FDA published its Resiliency Roadmap for FDA Inspectional Oversight.

This report outlines the agency’s inspection activities during the COVID-19 pandemic and its detailed plan to move toward a more consistent state of operations, including the FDA’s priorities related to this work going forward.

Among other things, the report highlights:

  • From March 2020 through March 2021, the FDA conducted a total of 821 mission-critical inspections, including 29 in foreign countries.
  • Additionally, the agency conducted a total of 777 prioritized domestic inspections since resumption of that work in July 2020.
  • Of the more than 13,500 applications for medical product approval or authorization received since March 2020, an estimated 68 applications have been delayed due to the inability to conduct inspections — and a majority of those are not deemed mission critical.
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