The U.S. 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 plant, in Sturgis, Mich., came to national attention in 2022 after the Food and Drug Administration, 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, F.D.A. records show. Abbott voluntarily ceased production at the plant for several months.
Baby formula was already somewhat scarce because of pandemic-related supply chain issues, but the Abbott recall made the situation much worse. Stunned 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 United States.
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 F.D.A. inspectors who swabbed the area near production lines at the Sturgis plant found samples of the bacteria, F.D.A. records show, no strain associated with an infant was directly linked to the facility.
Lawmakers held hearings about the crisis, discussing the F.D.A.’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.’”
In one House hearing in May, Dr. Robert Califf, the F.D.A. commissioner, acknowledged that the agency moved too slowly to address the supply chain crisis and made “decisions that were suboptimal along the way.”
He also described “shocking” and “egregiously unsanitary” conditions at the Sturgis plant, including a leaking roof and pooled water near production areas.
The F.D.A. released a review of its response in September, noting that the agency needs better information technology and visibility into the supply chain, even as formula supply remained low. Dr. Califf commissioned a more sweeping review of the F.D.A. food division, released last month, which called for a stronger new leadership structure.
Glenn Thrush contributed reporting.