The CDC said it found no match between bacteria samples from two sick infants and samples from a Michigan formula factory that paused production earlier this year.
infection in the four infants, who had all ingested powdered formula from the plant, but the Centers for Disease Control and Prevention and the Food and Drug Administration told NBC News they found no match between bacteria samples taken from two of the infants and samples from the factory.
Abbott said in a statement that it “continue[s] to enhance our manufacturing and quality processes to ensure that our products remain free of Cronobacter Sakazakii” and has “already begun implementing corrective actions and enhancements at the facility.” Abbott’s pause in production has exacerbated what was already a shortage of formula due to supply chain issues.
CDC typically receives reports of two to four Cronobacter infections per year, and an FDA spokesperson says concerns were raised when FDA personnel realized all four infants had consumed powdered formula from the same factory.between Jan. 31 and March 18 in response to the cases, inspectors found the factory failed to “establish a system of process controls covering all stages of processing” to prevent contamination.
The FDA inspection report also referenced how the company had apparently deviated from its own standard operating procedure. An earlier inspection of the plant in September 2019 also found that Abbott “did not test a representative sample” of powdered infant formula to meet the company’s “microbiological quality standards” before distribution. Following discussion with the FDA, Abbott says it updated its protocols to test from a larger number of containers.
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