Abbott Laboratories agreed to pay $385 million to settle U.S. allegations related to poor manufacturing practices at two facilities, including one involving an investigation of a contaminated facility that made powder infant formula.
The accord resolves claims that the company caused U.S. and state programs to buy powdered formula made in a way that put the products at “an unacceptable risk of microorganism contamination and significantly impacted” their “reliability, quality, and safety,” the Justice Department said in a statement Monday.
Food and Drug Administration inspectors found unsanitary conditions at an Abbott factory in Sturgis, Michigan, during a 2022 visit that led the company to shut down the plant and sparked a nationwide infant formula shortage. Inspectors also found strains of the deadly bacteria called Cronobacter sakazakii at the plant though none definitively linked the facility to sick babies. Several months later, Abbott entered a consent decree that gave the FDA oversight of the Sturgis facility for five years.
Related: Abbott to Pay $670 Million to Settle Some Preterm Infant Formula Cases
“No company should be gambling on the health and safety of our nation’s infants by allowing unsanitary conditions to persist at a facility manufacturing baby formula,” Associate Attorney General Stanley E. Woodward Jr. said in the statement.
Settling the lawsuit in the Western District of Michigan is not admission of fault or liability by Abbott, the company said.
...Abbott Laboratories agreed to pay $385 million to settle U.S. allegations related to poor manufacturing practices at two facilities, including one involving an investigation of a contaminated faci...