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FDA’s domestic inspections return to normal; overseas inspections still affected

For the first time since March 2020, the FDA’s inspections of US-based biopharma sites have returned to normal, FDA acting commissioner Janet Woodcock said.

“I’m pleased to say that as of this month, we’ve begun transitioning back to standard operations for domestic inspections while continuing to prioritize mission-critical work for foreign inspections,” Woodcock said.

The agency said it postponed nearly 8,000 non-mission-critical surveillance inspections in 2020 due to the pandemic. Surveillance inspections are routine inspections that monitor conformance to FDA requirements to identify quality problems and adverse trends. Unlike other inspections, these are planned in advance.

“FDA estimates that roughly 14 percent of the 15,514 domestic surveillance inspections still to be conducted in FY21 will be achievable in the Base-Case scenario,” an FDA report from May this year said. About 3,229 of those 15,514 inspections are related to human and animal drugs.

However, the agency is still struggling with foreign inspections, which are difficult to conduct during the pandemic. The FDA has successfully conducted only about 30 foreign inspections that were mission critical. [PharmaCompass]

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