According to the United States Department of Justice, a complaint and a proposed consent decree were filed in the U.S. District Court for the Western District of Michigan on May 16, 2022. If approved by the court, Abbott Nutrition would be allowed to take corrective actions at its Sturgis, Michigan facility and resume manufacturing powdered infant formula.
The complaint alleges that Abbott, as well as three of its principals, manufactured the powdered infant formula under conditions that did not comply with the federal Food, Drug, and Cosmetic Act (FDCA) and the U.S. Food and Drug Administration’s (FDA) Good Manufacturing Practice Requirements. These regulations mandate quality and safety standards for infant formula production, notably including protection against the risk of contamination from bacteria. According to the complaint, FDA testing of environmental samples at the Sturgis plant in February 2022 detected Cronobacter sakazakii in the manufacturing facility. The complaint further alleges that the products were adulterated, because they were made under insanitary conditions, in violation of the Good Manufacturing Practice Requirements.
Abbott Nutrition voluntarily shut down its Sturgis facility and recalled certain powdered infant formula products while the FDA inspection was ongoing. The FDA has indicated that the re-opening is a high priority, to mitigate the shortage of infant formula while also protecting public health. To resume production under the consent decree, Abbott will retain outside experts to bring the Sturgis facility into compliance with the regulations. Abbot will implement, among other things, plans for sanitation and environmental monitoring, as well as employee training programs.
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