Justice Department Investigates Abbott Infant Formula Manufacturing

NEW YORK. The US Department of Justice is investigating Abbott Laboratories’ infant formula plant in Michigan, which was closed for months last year due to contamination, the company confirmed.

The February 2022 factory closure was a key reason for shortages of infant formula across the country, forcing parents to seek formula from food banks, friends and doctors’ offices. Production resumed in June.

The Justice Department has briefed Abbott on its investigation, and the company is “fully cooperating,” Abbott spokesman Scott Stoffel said in an email. He declined to give further details.

The investigation was first reported by The Wall Street Journal, which says the Justice Department’s Consumer Protection Unit is investigating behavior at the Sturgis, Michigan plant that led to its closure.

Abbott closed the factory after the Food and Drug Administration launched an investigation into four bacterial infections among infants who ate powdered formula from the factory. Inspectors identified a number of irregularities at the plant, including bacterial contamination, a leaky roof, and non-compliance with safety protocols. But Abbott said its products have not been directly linked to infections involving various bacterial strains.

Abbott is one of four companies that make 90% of US infant formula, and the February recall of several leading brands, including Similac, reduced inventory that was already depleted due to supply chain disruptions and stockpiling during shutdowns from – for COVID-19.

The shortage has been particularly acute for children with allergies, digestive problems and metabolic disorders who rely on special formulas. The Abbott factory is the sole source for many of these products.

The FDA has faced harsh criticism for taking several months to close the plant and then agree to reopen it.