The US Department of Justice is investigating Abbott Laboratories’ infant formula plant in Sturgis, Michigan, a company spokesman confirmed to CNN.
“The DOJ has notified us of its investigation and we are fully cooperating,” the statement emailed to CNN said.
The investigation was first reported by the Wall Street Journal.
The plant was shut down for months last year after a US Food and Drug Administration inspection found several areas infected with Cronobacter sakazakii bacteria, which can be fatal to infants.
Plant-made powdered infant formulas from Similac, Alimentum and EleCare were recalled, and the closure exacerbated an infant formula shortage that was troubling families across the country.
After months of closure, Abbott’s Sturgis facility reopened in June with production of EleCare specialty formula. Production was underway for less than two weeks before a storm and flooding prompted authorities to close the plant again. In July it was restarted.
In April, Abbott submitted a corrective action plan to the FDA. In May, a federal judge signed an agreement between the FDA and Abbott outlining the steps the company needed to take to resume production.
“We understand the urgent need for formulas, and our top priority is to provide families across America with high-quality, safe formulas,” Abbott said in his statement at the time. “We will ramp up production as quickly as possible while meeting all requirements. We are committed to safety and quality and will do everything we can to regain the trust that parents, carers and healthcare providers have placed in us for 130 years.”
President Joe Biden invoked the Defense Production Act to direct suppliers of formulation ingredients to prioritize delivery to formulation manufacturers. The administration also launched Operation Fly Formula to import formula from abroad.