After being at the center of the infant formula shortage last year, Abbott Laboratories’ Michigan plant is reportedly facing a criminal investigation by the U.S. Department of Justice.
According to the Wall Street Journal, the Sturgis plant — which shutdown amid recalls on formula after complaints of bacterial infections — will be investigated for conduct. Attorneys for the DOJ’s consumer-protection branch are leading the criminal probe, WSJ said, citing people close to the matter.
“DOJ has informed us of its investigation and we’re cooperating fully,” an Abbott spokesman told Reuters, but did not comment further on the nature of the investigation.
Abbott is the biggest U.S. supplier of baby formula.
Last year, the White House had to intervene following the pandemic-induced infant formula shortage, which was only exacerbated by Abbott’s recall of Similac and other products produced at their Michigan facility, after reports of Cronobacter bacterial infections in babies. The U.S. Food and Drug Administration found “egregiously unsanitary” conditions during an inspection in May, such as cracks in vital equipment, a lack of adequate hand-washing and evidence of previous bacterial contamination.
“Frankly, the inspection results were shocking,” FDA Commissioner Robert Califf told House lawmakers on the Oversight and Investigations subcommittee, according to CNBC. “This is so far removed from my previous experience with the company that I am very concerned.”
The regulator and the company later reached an agreement that allowed the plant to reopen. But, less than two weeks after operations began, Abbott Nutrition once again shut down the plant in June, due to heavy rains and flooding. Production of products resumed in August.
The DOJ will now conduct their investigation, while, according to ABC News, FDA officials continue on with their own probe.