Watchdog opens investigation into FDA response to formula recall

A federal watchdog on Thursday said it will investigate whether the Food and Drug Administration (FDA) properly inspected an infant formula manufacturing plant operated by Abbott Nutrition.

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

Specifically, the watchdog will examine the FDA’s inspection of the plant 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 the agency’s response was too slow and said the FDA made a number of missteps that exacerbated a nationwide shortage of baby formula. Califf pledged to reform the agency’s often criticized food safety division.

The manufacturing plant in Michigan operated by Abbott Nutrition was shut down in mid-February following an FDA inspection that found unsanitary conditions and multiple strains of a bacteria that can 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 facility. 

Just four companies are responsible for 90 percent of the formula market. When Abbott’s plant shut down, the effects cascaded down a supply chain that was already strained because of the pandemic. 

The FDA has come under fire for failing to realize the severity of the problem until too late. 

The agency first conducted a “routine surveillance inspection” of Abbott’s plant in September 2021 following reports of bacterial infections in babies potentially linked to Abbott’s formula, but did not follow up with another inspection until Jan. 31. The recall wasn’t issued until Feb. 17.

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

But top agency officials — including the acting director and the top official in charge of food safety — never saw the report, and nobody at the FDA even requested an interview with the whistleblower until December, according to Califf’s testimony.