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FDA shares plan for restarting facility inspections, warns backlog will persist into 2022

FDA postponed all routine inspections in March 2020. The agency continued doing mission critical inspections, carrying out eight device-related assessments and more than 800 in total from March 2020 to March 2021. In July, FDA resumed prioritized domestic inspections and has since conducted 72 device assessments.

The activity has failed to prevent the build of a backlog of inspections. FDA has delayed seven device application decisions solely due to pending inspections or facility assessments, although none of the filings are considered mission critical by the agency. As of March, FDA was yet to do 12 of the for-cause device inspections it plans to complete this fiscal year, which runs to the end of September.

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