The FDA has just sent new warning letters to three formula companies, red-flagging quality control concerns.
Normally fully stocked shelves of baby forumala are empty in a Target store in Queens, New York, June 23, 2022.The FDA has sent warning letters to three formula companies, red-flagging concerns about serious quality control issues at some manufacturing facilities.
Two of the infants subsequently died, though Abbott maintains no conclusive evidence has proven its formula caused the babies' illnesses. But Abbott's ultimate shutdown ricocheted from coast to coast, leaving a serious void in the market and forcing families to face empty shelves and scramble for alternatives for months.
The letters describe multiple occasions where the FDA says finished formula tested positive for Cronobacter and instances where the companies had failed to sufficiently investigate the contamination's source and prevent it from happening again. Reckitt also found Cronobacter in their finished formula product at multiple facilities in the fall of 2022.
FDA investigators say they also found Cronobacter from swabbing their facility's environment this March -- noting in their letter that this "was not the first time" they had found it at that facility.
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