FDA plans to restart facility inspections that plummeted

The Food and Drug Administration is ratcheting up a wide range of facility inspections that were delayed by travel pauses after the pandemic began.

The inspections have long been a crucial tool to ensure that drugs are contaminant-free, device flaws are fixed and the food supply is sanitary. If agency inspectors find serious problems, they usually require improvements — but they also can seize goods, or pursue civil or criminal penalties.

Typically in recent years, the FDA inspected about 12,500 U.S. facilities annually, a number that fell by about half, to about 6,100, in 2021. Foreign inspections — the agency visits facilities making products for the American market — fell even more precipitously, from more than 3,100 in the years before the pandemic to 167 in 2021.

In recent months, FDA inspections have turned up alarming problems. A consumer complaint led federal inspectors to a Family Dollar distribution facility in Arkansas in January, where they found live and dead rodents “in various states of decay.”

A review of company documents revealed that 2,300 rodents had been collected since March 2021. A recall of a wide array of food, medications, cosmetics and dietary supplements followed.

FDA inspectors have also been probing Abbott Nutrition’s baby formula manufacturing facility in Sturgis, Mich., after the company reported finding Cronobactor sakazakii bacteria during its own routine testing.

The company has also issued a recall. The investigation includes five infant hospitalizations and may have contributed to two deaths.

An estimated 73% of the facilities making active drug ingredients for the U.S. market are overseas. The federal Government Accountability Office has raised concerns about the inspection lapse and staff vacancies among foreign inspectors.

The FDA said Friday that “mission critical” inspections never ceased, even as the agency halted travel to ensure the safety of its workforce during virus surges in the pandemic. Domestic inspections resumed again in February after a pause during soaring cases of the omicron variant. The FDA plans to return to its “normal cadence” of overseas inspections in April.

The FDA “is working as quickly and as safely as possible to resume normal operating status for inspections that prioritize public health,” a spokesperson, Jeremy Kahn, said in an email.

In the United States and abroad, the dip in inspections came with a drop in enforcement actions, such as warning letters, injunctions and product recalls, according to an analysis by the law firm Skadden, Arps, Slate, Meagher & Flom.

Enforcement shifted focus as well, a partner, Jennifer Bragg noted, zeroing in more on unsubstantiated claims about the testing and treatment of the coronavirus.

One unintended consequence of a new wave of inspections could be that companies halt production while responding to problems that FDA officials find, exacerbating current medication or sterile injection fluid shortages.

That happened years ago, when the agency focused on overseas blood-thinner makers after sterility lapses were tied to dozens of deaths in the United States, said Erin Fox, a drug shortage expert at the University of Utah.

“Are we going to have a repeat of that?” Fox wondered. “Just quality in general is really important.”