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At Best, FDA Will Carry Out Only Half Of Domestic Surveillance Inspections In FY 2021, Report Says

Agency vows to create Inspectional Affairs Council, modernize its regulatory oversight approach

 
• By Shawn M. Schmitt

A 5 May report from the US FDA says that even under the most favorable COVID-19 conditions the agency’s inspections of makers of medical and tobacco products will likely be cut in half this fiscal year. The FDA also announced it will launch an agency-wide Inspectional Affairs Council to “plan and coordinate inspectional activities.”

Enlarged eye of tax inspector looking through magnifying glass, inspecting offshore company financial papers, documents and reports.

In a best-case scenario described by a new US Food and Drug Administration report, the agency will conduct half of its planned domestic surveillance inspections this fiscal year, which will end on 30 September.

The 5 May report, “Resiliency Roadmap for FDA Inspectional Oversight,” says the agency still has 3,229 surveillance inspections to carry out in FY 2021 of manufacturers of human and...

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