Update on the FDA investigation of Cronobacter infections in powdered infant formula

The FDA released Form 483s from three inspections conducted at Abbott Nutrition's facility in Sturgis, MI on September 16-24, 2019, September 20-24, 2021, and January 31-March 18, 2022. Important observations from the 2022 form 483 include the failure to establish a system that prevents contamination of microorganisms in the formula or in the processing environment. Abbott Nutrition did not ensure that all surfaces that contacted infant formula were maintained to protect infant formula from being contaminated by any source. The FDA has reported that this year's inspection showed positive test results from environmental samples for Cronobacter. The organism was found on environmental surfaces in the packaging room and on the floor near a dryer. Cronobacter sakazakii was found by the company lab in a sample of infant formula in September of 2019, and in another sample in June of 2020 @ https://www.fda.gov/food/outbreaks-foodborne-illness/fda-investigation-cronobacter-infections-powdered-infant-formula-february-2022?utm_medium=email&utm_source=govdelivery


 Cronobacter and Salmonella Complaints about Powdered Infant Formula
Cronobacter and Salmonella Complaints about Powdered Infant Formula

Do not use recalled Similac, Alimentum, or EleCare powdered infant formulas produced at Abbott Nutrition’s Sturgis, MI facility

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