The Department of Justice (DOJ) has launched a criminal investigation into the Abbott Laboratories plant in Michigan that shut down last year and exacerbated a nationwide baby formula shortage.
Company spokesman Scott Stoffel confirmed to The Hill on Saturday that the DOJ informed Abbott of the investigation and that Abbott is fully cooperating. Abbott, one of the country’s largest producers of baby formula, recalled multiple baby formula powder products in February after two infants died from a rare infection after consuming some of the company’s products made at its plant in Sturgis, Mich.
Stoffel said he had no further details to provide.
The Food and Drug Administration (FDA) said it found evidence of unsanitary conditions at the plant and that multiple strains of bacteria that can be deadly to infants were present in the facility.
The recalls aggravated a supply chain issue that was already in progress as a result of supply struggling to keep up with demand amid the COVID-19 pandemic. Production at the Sturgis plant resumed in July.
The Wall Street Journal first reported on the DOJ investigation.
Abbott has said its products and the bacteria have not been directly tied to the infections that killed the infants.
A whistleblower reportedly warned Abbott and the FDA of possible issues with the Sturgis plant in February 2021, a year before it was shut down. The complaint said formula was being distributed without proof of safety and that some equipment involved in producing it needed to be fixed.
Abbott Nutrition said in October that it plans to build a $500 million facility for specialty and metabolic infant formulas to increase domestic manufacturing. It also said it had made changes to the leadership of the Sturgis plant.
The DOJ declined to comment.
Updated on Jan. 22 at 1:44 p.m.