Justice Department investigates Abbott infant formula factory

Abbott halted production at the plant last year due to 'shocking' sanitation shortcomings, causing a disruptive shortage of supply of infant formula.

The United States Department of Justice has opened an investigation into the operations of the Abbott Nutrition infant formula factory in Michigan which closed opened due to sanitation issues early last year, causing a long and widespread shortage of infant formula.

The company has confirmed the investigation in an email but didn't provide any other details other than that she was "cooperating fully," according to an Abbott spokesperson.

The plant, in Sturgis, Michigan, came to national attention in 2022 after the Food and Drug Administration, while reporting cases of no infants sickened by formula produced there, found surprisingly 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.

Infant formula was already somewhat scarce due to supply chain issues related to the pandemic, but Abbott's recall made matters worse. Stunned parents said they hunted for hours to find the formula needed to feed their babies. In May, President Biden was deploying military aircraft to airlift infant formula to the United States.

The investigation had previously been 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 bacteria Cronobactor sakazakii beginning in September 2021, and two of them died. Although the F.D.A. inspectors who swabbed the area near the Sturgis plant's production lines found samples of the bacteria, F.D.A. records show that no strain associated with an infant was directly linked to the facility.

Lawmakers held hearings on the crisis, discussing the trial and error of the FDA over a whistleblower complaint from an Abbott insider who claimed the factory did not destroy a batch of the preparation containing microorganisms because "senior management was under significant pressure to meet its 'numbers' '".

During a House hearing in May, Dr. Robert Califf, the F.D.A. commissioner, acknowledged that the agency moved too slowly to resolve the supply chain crisis and made "suboptimal decisions along the way".

He also described "shocking" and "extremely unsanitary conditions" at the Sturgis plant, including a leaky roof and standing water near production areas.

The F.D.A. released a review of its response in September, noting that the agency needed better information technology and supply chain visibility, even as formula supply remained low. Dr. Califf commissioned a more in-depth examination of the F.D...