The U.S. Justice Division is investigating the Abbott Laboratories toddler formulation plant in Michigan that was shut down for months final yr on account of contamination, the corporate confirmed.
The manufacturing facility’s closure in February 2022 was a key reason for a nationwide child formulation scarcity that compelled dad and mom to hunt formulation from meals banks, pals and physician’s workplaces. Manufacturing restarted in June.
The Justice Division has knowledgeable Abbott of its investigation and the corporate is “cooperating totally,” Abbott spokesperson Scott Stoffel stated by way of electronic mail. He declined to supply additional particulars.
The investigation was first reported by The Wall Avenue Journal, which stated the Justice Division’s client safety department is wanting 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 formulation 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 acknowledged that its merchandise haven’t been straight linked to the infections, which concerned completely different bacterial strains.
Abbott is considered one of simply 4 firms that produce 90% of U.S. formulation, 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 youngsters with allergic reactions, 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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