Inspections: GAO calls on FDA to plan for backlog, review alternatives
In a nearly 350-page report to Congress on the federal government’s Covid-19 response, the Government Accountability Office (GAO) calls on the FDA to review its inspections approach and come up with a plan to address its looming backlog.
Pandemic inspection alternatives
In the early days of the pandemic, FDA halted non-mission-critical foreign and domestic inspections and relied on alternative tools, such as inspection reports from foreign regulators, records requests and product sampling, to complement its oversight activities. The agency has since resumed some prioritized domestic inspections based on a rating system and, according to Acting Center for Drug Evaluation and Research Director Patrizia Cavazzoni’s recent Twitter post, “FDA has begun conducting prioritized inspections by investigator staff in China and is planning to initiate prioritized inspections in India shortly.”
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