From September 2021 to February 2022, the CDC received reports of Cronobacter bacteria cases in infants in Minnesota, Ohio and Texas that resulted in four illnesses with two deaths. These illnesses were ultimately linked by the CDC and FDA to the consumption of powdered infant formula produced by Abbott in its Sturgis, Michigan facility. A worldwide recall of formula produced in the plant has left store shelves bare and parents scrambling for safe alternatives to feed their babies.
According to the CDC, Cronobacter can cause severe, life-threatening infections or meningitis. Although Cronobacter infections are rare, they can be deadly in newborns in the first days or weeks of life with a mortality rate between 50% and 80%. Only a handful of Cronobacter infections are reported yearly, but given only the state of Minnesota requires labs to report positive tests, it is unclear how many illnesses are missed.
How did the FDA find itself facing thousands of scared and angry parents? It is a history of warning signs ignored.
In September 2019, the last time the FDA inspected the facility, the FDA cited Abbott for failing to test an adequate amount of formula to assure that it met “the required microbiological quality standards.”
In September 2021, after two years with no on-site inspection, the FDA returned to Abbott and found several concerning practices that likely lead to formula contamination, specifically, Abbott failed to “maintain a building used in the manufacture,...
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