Abbott Laboratories is under investigation by the U.S. Justice Department, the company confirmed Friday, nearly a year after it shut down a Michigan baby food factory after reports of illnesses.
Abbott did not specify what aspect of the company is overseen by the Justice Department.
“DOJ has notified us of its investigation and we are cooperating fully,” an Abbott spokesperson said in a statement to NBC News.
The Wall Street Journal reported earlier Friday that the Justice Department was investigating conduct at Abbott’s Sturgis, Michigan, plant, citing people familiar with the case who did not name it. 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 stopped production at its Sturgis baby food factory on February 17, 2022, after babies consuming factory-made formula became ill.
The closure contributed to a nationwide shortage of infant formula.
Four babies, two of whom died, fell ill with a rare bacteria after consuming powdered formula made at Abbott’s Michigan plant.
Federal investigators were unable to definitively pinpoint 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 outlining what it would do before reopening its plant.
The Food and Drug Administration said when the proposed consent decree was announced that “the government alleges that powdered infant formula products manufactured at Abbott Nutrition’s Sturgis facility have been adulterated because they were made under unsanitary conditions and in violation of current requirements for good manufacturing practices.”
Production at the Michigan plant, which makes three of the country’s most popular brands – Similac, Alimentum and EleCare – resumed in June.
Abbott Labs previously said it is “ongoing[s] to improve our manufacturing and quality processes to ensure our products remain free of Cronobacter Sakazakii” and had “already begun implementing corrective actions and facility improvements.”
The company also said the lack of a genetic match between sick babies and formula confirmed its own internal tests that showed there was no link, and that it did not find the bacteria in any of the products it distributed.