How The European Medicines Agency Inspected Thermo Fisher’s Florida Plant Without Leaving Europe
Contract development and manufacturing organization relied on combination of immersive mixed-reality devices to host remote inspection.
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Compared to FY2019, FDA data show agency inspections of OTC and Rx drug manufacturing facilities in FY2020 fell 60%. As pandemic continues in FY2021, inspection rate will remain depressed, and it remains unclear how the agency will reduce the backlog without resorting to remotely conducted inspections.
FY2020 review highlights drop in inspections, preparations for growing backlog, and pandemic test of Janet Woodcock’s 21st Century proposition – developments that will likely reverberate in the years ahead.
Agency’s struggle to meet user fee commitments despite travel restrictions expected to worsen as pandemic continues into 2021.