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AP: FDA skipped most baby formula plant inspections in 2020

FILE - A few containers of baby formula are left on the shelves of a grocery store in Carmel, Ind., May 10, 2022. A bill introduced in June 2022 would require the Food and Drug Administration to inspect infant formula factories every six months. U.S. regulators have historically inspected baby formula plants at least once a year, but the AP found they did not inspect any of the three biggest manufacturers in 2020. (AP Photo / Michael Conroy, File)


When the executives of the three biggest baby formula manufacturers testified on Capitol Hill, Washington-based health and science reporter Matthew Perrone listened as each named the precise locations of their main U.S. factories — information the companies don’t usually release.

Perone turned that seemingly mundane testimony into a timely scoop, breaking the news that the Food and Drug Administration had skipped nearly all its inspections of baby formula plants during the first year of COVID, likely contributing to the severe shortage of formula in the U.S. and raising questions about what the federal government could have done to prevent it.

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The Abbott Laboratories manufacturing plant in Sturgis, Mich., Sept. 23, 2010. – Brandon Watson / Sturgis Journal via AP

Armed with the plant locations, Perrone had identified the factories in the FDA’s online inspection database and discovered the agency didn’t inspect Abbott Laboratories’ plant — responsible for a recall of formula that exacerbated the nationwide shortage — for two years between 2019 and 2021. Previously, the FDA had inspected all U.S. formula plants annually. Perrone’s reporting also showed that Abbott wasn’t alone — the FDA didn’t inspect any of the top three formula makers in 2020. In fact, FDA inspectors still have not returned to three facilities run by Reckitt and Gerber that are now operating 24/7 to boost supplies.

FDA press officials challenged the story’s premise and delivered an 800-word response on how formula had consistently been a “high priority” for the agency, despite having almost no presence among its “mission critical” inspections in 2020. When AP pressed for specifics, the FDA acknowledged only three of the nation’s 23 formula plants were inspected in the first year of the pandemic.

The exclusive story played widely,and during a Senate hearing later in the week,Sen. Tim Kaine,D-Va.,cited Perrone’s reporting and said inspectors should be considered “essential workers.” FDA Commissioner Robert Califf said he agreed with the point. “Definitely inspections were put on hold and there’s a price we pay for that,” Califf said.

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