Friday, May 21, 2021 9:58:55 AM
For decades, the Government Accountability Office (GAO) has raised concerns about the US Food and Drug Administration’s (FDA) inspections program. Now, a year after the agency halted most of its foreign and domestic inspections due to the COVID-19 pandemic, GAO warns that the ensuing backlog could take years to clear.
In a new report and testimony before the House Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies, GAO Health Care Director Mary Denigan-Macauley, PhD, said that the agency needs to come up with a plan to address the looming inspections backlog and tackle some of its longstanding issues.
FDA conducts three types of inspections: preapproval inspections, routine surveillance inspections and for-cause inspections. For routine surveillance inspections, FDA considers inspections of sites that have never been inspected and those that have not been inspected within five years to be mandatory and prioritizes its remaining resources on inspecting establishments based on risk.
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