Watchdog launches investigation into FDA response to formula recall

(The Hill) – A federal watchdog said Thursday it would investigate whether the Food and Drug Administration had properly inspected an infant formula manufacturing plant operated by Abbott Nutrition.

The Office of the Inspector General for the Department of Health and Human Services said it will investigate FDA actions leading up to the February recall at Abbott’s Michigan facility.

Specifically, the watchdog will examine the FDA’s inspection of the factory as well as how the agency oversaw Abbott’s initiation of the infant formula recall.

The review is expected to be completed by 2023, the OIG said.

FDA Commissioner Robert Califf admitted to lawmakers last week that the agency’s response was too slow and said the FDA had made a number of missteps that had exacerbated a national infant formula shortage. . Califf has pledged to reform the agency’s oft-criticized food security division.

The Michigan manufacturing plant operated by Abbott Nutrition was closed in mid-February following an FDA inspection that found unsanitary conditions and multiple strains of bacteria that could be deadly to infants.

At the same time, the company issued a nationwide recall for all brands of powdered formula that had been manufactured at the plant.

Just four companies are responsible for 90% of the formulas market. When Abbott’s factory closed, the effects rippled through an already strained supply chain due to the pandemic.

The FDA has been criticized for not realizing the seriousness of the problem until too late.

The agency first conducted a “routine surveillance inspection” of Abbott’s factory in September 2021 following reports of bacterial infections in babies potentially linked to Abbott’s formula, but did not was not followed by another inspection before January 31. The recall was not issued until February 17.

A former Abbott employee sent the FDA a 34-page report in October outlining a host of unsanitary conditions at the company’s Michigan plant.

But senior agency officials — including the acting director and top food safety official — never saw the report, and no one at the FDA even requested an interview with the whistleblower. until December, according to Califf’s testimony.

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