Abbott Laboratories is under investigation by the US Department of Justice, the company confirmed on Friday, nearly a year after it shut down a Michigan infant formula plant after illnesses were reported.
Abbott did not specify which aspect of the business is under the Justice Department’s control.
“The DOJ has notified us of its investigation and we are cooperating fully,” a spokesperson for Abbott said in a statement to NBC News.
The Wall Street Journal reported earlier Friday that the Justice Department was investigating conduct at Abbott’s plant in Sturgis, Michigan, citing people familiar with the matter whom it did not name. NBC News has not independently confirmed the nature of the investigation. The Justice Department did not immediately respond to a request for comment from NBC News.
Abbott voluntarily halted production at its Sturgis infant formula manufacturing plant on February 17, 2022, after infants consuming infant formula made at the plant fell ill.
The shutdown contributed to a nationwide shortage of infant formula.
Four infants, two of whom died, were sickened by a rare bacteria after consuming formula made at Abbott’s Michigan plant.
Federal investigators have not been able to definitively determine the source or sources of the bacteria, Cronobacter sakazakii, which can cause serious illness.
The company signed a consent decree with the federal government in May that spells out what it would do before reopening its plant.
The Food and Drug Administration said when announcing the proposed consent decree that “the government alleges that powdered infant formula manufactured at Abbott Nutrition’s facilities in Sturgis has been adulterated because it was manufactured in unsanitary conditions and in violation of current good manufacturing practice requirements”.
Production at the Michigan plant, which makes three of the country’s most popular brands – Similac, Alimentum and EleCare – resumed in June.
Abbott Labs has previously stated that it “continues[s] to improve our manufacturing and quality processes to ensure our products remain free of Cronobacter Sakazakii” and had “already begun to implement corrective actions and improvements in the facility”.
The company also said the lack of a genetic match between the sick infants and the formula confirmed its own internal tests showing there was no link, and it said it only found the bacteria in any of its distributed products.