STAT+: FDA oversight of pharma manufacturing facilities plunges during the pandemic
Each year, the Food and Drug Administration tracks its progress inspecting pharmaceutical manufacturing facilities and issuing follow-up letters for plants that require significant fixes. But in the most recent fiscal year, there was a significant drop in productivity.
Specifically, the agency sent just 70% of letters that should have gone out to summarize the final regulatory classification for facilities within 90 days of an inspection. And only 48% of regulatory actions were completed within six months for manufacturing plants that had quality control problems that needed to be addressed, according to the report.
