FDA Faces Backlog of 2,000 Uninspected Drug Plants Post-COVID

The pandemic halted inspections, and staff shortages have delayed the FDA's efforts to catch up, raising concerns over drug safety.

42% of drug manufacturing plants registered with the FDA haven't been inspected since before May 2019.
The FDA's inspection workforce has 225 vacancies, nearly four times the pre-pandemic number.
Most overdue inspections are for plants in the US, India, and China, key producers of generic drug ingredients.
The FDA has increased inspections since 2021 but remains 40% below pre-pandemic levels.
Significant violations have been found in some overdue plants, including unsanitary conditions and document tampering.