The FDA has just sent new warning letters to three baby formula companies, red-flagging quality control concerns.
ByThe FDA has sent warning letters to three formula companies, red-flagging quality control issues at some manufacturing facilities.
Cronobacter can be widely found in the environment -- but in infants, it can be deadly. Its discovery inside Abbott's Sturgis, Michigan, plant last year prompted a massive voluntary formula recall in February 2022 after four babies who had consumed Abbott's formula contracted a Cronobacter infection.
The new warning letters detail some of the same concerns that ABC News was first to report last year. And though the companies took corrective actions, the agency said more is needed after these recent inspections. FDA's findings at Reckitt's facility came amid months where the company had also found Cronobacter in "high and critical hygiene zones" of their facility's environment -- from July 2022 to February 2023.
In the new warning letter sent to Perrigo, the FDA details that Cronobacter had been identified in finished formula products on multiple occasions by the company: in two products "during a continuous production campaign that ran from Oct. 23, 2022, to Nov. 2, 2022," another that ran from Jan. 3, 2023, through Jan.
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