Abbott will pay $385 million to resolve state, federal and civil lawsuits related to the manufacturing of a baby formula at a Michigan plant where deadly contamination issues emerged, the U.S. Justice Department announced Monday.

Abbott triggered a national shortage of baby formula when contamination issues at a manufacturing plant in Sturgis, Michigan in early 2022 forced the company to recall millions of cans of the product.

U.S. prosecutors said “roof leaks were a common occurrence in the Sturgis plant, leading to water running and dripping over equipment.”

“Rather than permanently addressing the root causes, Abbott used temporary solutions, such as roof leak umbrellas, to try to divert leaks in product processing areas even though Abbott corporate leadership understood that the wet environment put the products at increased risk of microorganism contamination,” the Justice Department said Monday. “Similarly, the complaint alleged that Abbott continued to run spray dryers, where liquid formula was transformed into a dry powder, even after Abbott documented cracks and pits in the dryers, which also increased the risk of “micro” contamination, particularly in the presence of moisture.”

Acting Deputy Attorney General Trent McCotter called the settlement "a victory for American families and makes clear the safety of our children is not negotiable,”

“Abbott will pay a substantial sum to resolve serious allegations it violated federal health and safety requirements designed to protect babies. The Justice Department will act decisively against anyone who puts American families at risk and ensure misconduct carries serious consequences,” McCotter added.

In a statement Monday afternoon, Abbott said the agreement resolves “the previously disclosed investigation and lawsuit brought by the United States Department of Justice, as well as lawsuits filed by certain relators and the Attorneys General of several states, relating to Abbott’s manufacturing and 2022 recall of powdered infant formula at its facility in Sturgis, Mich.”

Abbott said the settlement “does not represent any finding of fault or liability.” The Justice Department has closed its criminal investigation.

In addition, Abbott on Monday said “no unopened, distributed Abbott infant formulas have ever tested positive for Cronobacter sakazakii .”

“Consistent with this, the FDA confirmed in early March 2022 that the unopened product from the homes of the infants under investigation at the time of the 2022 recall tested negative for Cronobacter sakazakii,” the company added. “The CDC later concluded there was no definitive link between the Sturgis facility and the clinical cases under investigation at that time.”

Still, the Justice Department was critical of the company’s handling of its manufacturing with a broader warning to manufacturers.

The shutdown of the Michigan plant contributed to a nationwide shortage of infant formula, particularly the more popular Similac that has long been a flagship brand of Abbott’s. The production of EleCare, however, was perhaps more important because the formula is hypoallergenic and used by infants and children with gastrointestinal disorders.

“No company should be gambling on the health and safety of our Nation’s infants by allowing unsanitary conditions to persist at a facility manufacturing baby formula,” said Associate Attorney General Stanley E. Woodward, Jr. “The Department will hold accountable bad actors that knowingly misrepresent compliance with essential health and safety standards designed to protect American families.”