Abbott faces criminal investigation over baby formula, says report

The Michigan plant came to national attention in 2022 after FDA, while fielding reports of infants sickened by formula produced there, found strikingly unsanitary co

The US Department of Justice has opened an investigation into operations at the Abbott Nutrition infant formula plant in Michigan that shut down over sanitation problems early last year, causing a lengthy and widespread infant formula shortage.

The company confirmed the investigation in an email but offered no further details, other than that it was “cooperating fully,” according to an Abbott spokesman.

The Michigan plant came to national attention in 2022 after the Food and Drug Administration (FDA), while fielding reports of infants sickened by formula produced there, found strikingly unsanitary conditions, including puddles of water on the floor near production lines. 

In February, the agency urged the company to recall Similac and other widely used infant formulas, FDA records show. Abbott voluntarily ceased production at the plant for several months. 

Baby formula was already scarce because of pandemic-related supply chain issues, but the Abbott recall made the situation much worse. Parents reported hunting for hours to find formula needed to feed their infants. By May, President Biden was deploying military planes to airlift infant formula into the US.

The investigation was previously reported by The Wall Street Journal. The Department of Justice declined to comment.

Four infants in three states — Minnesota, Ohio and Texas — fell ill with the dangerous Cronobactor sakazakii bacteria starting in September 2021, and two of them died. 

Though FDA inspectors who swabbed the area near production lines at the plant found samples of the bacteria, its records show, no strain associated with an infant was directly linked to the facility.

Lawmakers held hearings about the crisis, discussing the FDA’s fumbling of a whistle-blower complaint from an Abbott insider who asserted that the plant did not destroy a batch of formula found to include micro-organisms because “senior management was under significant pressure to meet its ‘numbers.’

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