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Perrigo Wisconsin, LLC was cited for significant violations of infant formula Current Good Manufacturing Practice (CGMP) requirements and quality control procedures under 21 C.F.R. Part 106 at its Gateway facility in Eau Claire, Wisconsin, following an FDA inspection from March through April 2023. The facility, recently acquired from Nestle in November 2022 along with the Good Start infant formula brand rights, was found to have manufactured adulterated infant formula in violation of the Federal Food, Drug, and Cosmetic Act. The company submitted corrective actions in May 2023, but FDA determined these actions were insufficient to address the serious compliance failures discovered during the inspection.