The FDA is returning to normal facility inspection operations, which were significantly disrupted by the COVID-19 pandemic, according to a March 21 report from The New York Times.
The agency's facility inspections aim to ensure drugs are contaminant-free, device flaws are fixed and the food supply is sanitary. While the FDA usually inspects about 12,500 U.S. facilities annually, that fell to about 6,100 in 2021, according to FDA data cited by the Times. The agency's foreign inspections of facilities making products for the American market, including drug ingredients, fell even more drastically, from more than 3,100 pre-pandemic to 169 in 2021.
The FDA resumed U.S. inspections in February after the omicron surge led to a halt. The agency plans to return to its "regular cadence" of foreign inspections in April. The agency said it never paused "mission critical" inspections. A spokesperson for the agency told the Times the FDA "is working as quickly and as safely as possible to resume normal operating status for inspections that prioritize public health."
A return to normal inspection operations could lead to the inadvertent consequence of worsening medication or sterile injection fluid shortages if companies halt production while responding to issues FDA inspectors find, experts told the news outlet.