GAO Advises US FDA On Inspection Pilot Plans; Notes Increased Oversight Of OAI Downgrades
As omicron COVID-19 variant recedes, GAO shares thoughts on FDA’s plans for unannounced foreign inspections and translation services pilots. The report also details agency efforts to fill vacant foreign inspection positions.
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After lapsing due to COVID-19, an unannounced foreign inspection pilot program is on track to resume in 2022, “despite challenges and constraints of travel.”
Additional hiring in FDA’s FY 2022 budget request also is expected to help address the inspections delayed by the coronavirus pandemic.
Hiring travails, inspection pre-announcement, lack of translators highlighted in congressional hearing on FDA foreign inspections.