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Before The Freeze: US FDA Inspection Data Pointed To Continued Foreign Facility Focus

 
• By Derrick Gingery

Until the coronavirus forced it to stop, the FDA had planned to up domestic and foreign inspections in FY 2020 and FY 2021, as the longer-term trend showed domestic inspections dropping and foreign inspections rising.

Pill Production
The FDA expects to increase domestic and foreign facility Good Manufacturing Practice inspections substantially in FY 2020 and FY 2021, compared to FY 2019. • Source: Shutterstock

Until the coronavirus forced it to stop all non-mission-critical inspections, the US Food and Drug Administration inspection workload was continuing to shift away from domestic facilities, with nearly all categories set for declines in fiscal years 2020 and 2021 compared to FY 2017.

Estimates in the FDA’s FY 2021 budget request point to how inspections are expected to progress once they resume and the backlog is cleared.

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