Preparing For The Return Of US FDA Inspections
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.
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Criticized for giving foreign sites advance notice of inspections, agency is considering giving such notice to domestic sites too even after surprise inspections become possible.
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.
Sedgwick reported US OTC drug recalls in 2020 doubled to 61 driven by methanol contamination and GMP deviations in hand sanitizers. Once FDA resumes full inspection schedule, enforcement will be “more frequent, penalties will be harsher and cross-agency collaboration” will be welcome.