NEW YORK — The U.S. Justice Division is investigating the Abbott Laboratories toddler method plant in Michigan that was shut down for months final yr resulting from contamination, the corporate confirmed.
The manufacturing facility’s closure in February 2022 was a key reason for a nationwide child method scarcity that pressured dad and mom to hunt method from meals banks, mates and physician’s places of work. Manufacturing restarted in June.
The Justice Division has knowledgeable Abbott of its investigation and the corporate is “cooperating absolutely,” Abbott spokesperson Scott Stoffel mentioned by way of e-mail. He declined to offer additional particulars.
The investigation was first reported by The Wall Road Journal, which mentioned the Justice Division’s client safety department is trying into conduct on the Sturgis, Michigan, plant that led to its shutdown.
Abbott closed the manufacturing facility after the Meals and Drug Administration started investigating 4 bacterial infections amongst infants who consumed powdered method from the plant. Inspectors uncovered a number of violations on the plant, together with bacterial contamination, a leaky roof and lax security protocols. However Abbott has said that its merchandise haven’t been immediately linked to the infections, which concerned totally different bacterial strains.
Abbott is considered one of simply 4 firms that produce 90% of U.S. method, and its February recall of a number of main manufacturers, together with Similac, squeezed provides that had already been strained by provide chain disruptions and stockpiling throughout COVID-19 shutdowns.
The scarcity was particularly acute for kids with allergy symptoms, digestive issues and metabolic issues who depend on specialty formulation. The Abbott manufacturing facility is the one supply of a lot of these merchandise.
The FDA has confronted intense criticism for taking months to shut the plant after which negotiate its reopening.
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