December 7, 2022

FDA: Abbott Didn’t Test Similac Samples in Internal Probe of Infant Death

Analysis Contrary to its own operating procedures, Abbott Nutrition completed an internal probe of a fatal Cronobacter case without testing samples of the associated lot of Similac Pro Total Comfort, according to the FDA's 2022 inspection report of Abbott's facility in Sturgis, MI. Federal health officials have been investigating four Cronobacter illnesses, two of them fatal, reported between September 2021 and January 2022 among infants who consumed Similac products made at Abbott's Sturgis plant. Yesterday, the U.S. Food and Drug Administration (FDA) released the reports from its three most recent inspections of the Sturgis facility. The reports show that Abbott failed to maintain sanitary conditions at the plant where it makes a variety of infant formulas including some for babies … [Read more...]

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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