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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Two firms in India, two in South Korea manufacturing toothpastes and hand sanitizers available in US didn’t respond to FDA’s repeated records requests. Six others in those two countries and Canada and Turkey making sanitizers and toothpastes, including products for children, as well as sunscreens were warned about GMP failures after providing records at agency’s request.
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.