December 7, 2022

Abbott Nutrition Form 483 Released by FDA in Cronobacter Illness Investigation

Abbott Nutrition Form 483 has been released by the FDA in the investigation of four Cronobacter illnesses linked to recalled Similac powdered infant formula. The three forms were released after inspections were conducted by the FDA at Abbott's facility in Sturgis, Michigan. All of the sick infants, who lived in Minnesota, Texas, and Ohio, are reported to have consumed powdered infant formula that was produced at that facility. The inspections were conducted on September 16 - 24, 2019, Sepatember 20 - 24, 2021, and January 31 - March 18, 2022. The notice states, "The inspectional observations in these Form 483s do not constitute final FDA determinations of whether any condition was or is in violation of the Federal Food, Drug, and Cosmetic Act or any of its implementing regulations. … [Read more...]

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