US FDA Inspections By The Numbers: Very Few During COVID
GAO report offers new data on the impact of COVID on FDA’s drug inspections. (It was big.)
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House lawmakers who get the first cut at setting the FDA’s budget joined GAO expert in raising concerns about shortage of investigators and lack of surprise for foreign inspections.
FDA also should more fully explore using alternatives to on-site inspections the pandemic prevents it from conducting, said Mary Denigan-Macauley, director of GAO’s health care office.
Agency must plan to ensure that a growing backlog of surveillance inspections does not impede its ability to conduct inspections at high-risk sites, GAO official says.