Justice Department investigating Abbott plant

NEW YORK — The U.S. Justice Department is investigating the Abbott Laboratories toddler components plant in Michigan that was shut down for months final yr as a result of contamination, the corporate confirmed.

The manufacturing unit’s closure in February 2022 was a key reason behind a nationwide child components scarcity that pressured mother and father to hunt components from meals banks, pals and physician’s workplaces. Production restarted in June.

The Justice Department has knowledgeable Abbott of its investigation and the corporate is “cooperating fully,” Abbott spokesperson Scott Stoffel mentioned through e-mail. He declined to offer additional particulars.

The investigation was first reported by The Wall Street Journal, which mentioned the Justice Department’s shopper safety department is wanting into conduct on the Sturgis, Michigan, plant that led to its shutdown.

Abbott closed the manufacturing unit after the Food and Drug Administration started investigating 4 bacterial infections amongst infants who consumed powdered components from the plant. Inspectors uncovered a number of violations on the plant, together with bacterial contamination, a leaky roof and lax security protocols. But Abbott has said that its merchandise haven’t been immediately linked to the infections, which concerned completely different bacterial strains.

Abbott is certainly one of simply 4 firms that produce 90% of U.S. components, 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 allergy symptoms, digestive issues and metabolic problems who depend on specialty formulation. The Abbott manufacturing unit 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.