Nine children died and dozens of other sick after eating breast milk substitute produced at a contaminated factory

As many as nine babies have died since early 2021 of possibly contaminated breast milk substitutes at a Michigan plant, according to new documents.

The Food and Drug Administration investigated these allegations and previously claimed that only two children had died and two others became ill after ingesting the Sturgis plant formula.

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However, the agency said Friday that there were several reports of more children dying or becoming ill after drinking the formula that allegedly contained the bacterium cronobacter sakazakii.

The FDA was unable to determine the source of the infection in all nine deaths, as in some cases there was not enough formula left to test.

For children who died of bacterial infections, test results showed strains other than those found at the Sturgis plant during an inspection.

Questions are now being raised about how Abbott Nutrition’s maintenance of the plant, which forms a large part of the country’s powder formula supply.

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There are also doubts about how the FDA handled complaints against the Sturgis plant, which was closed for five months due to safety concerns, resulting in a nationwide shortage of infant formula.

Reports of the baby’s death were included in a list of 128 consumer complaints collected by the FDA by the agency’s consumer complaint system between December and March.

The names of the children were not published and were only identified by the number of cases.

“The FDA takes its responsibility seriously to ensure that the foods we eat are safe and meet our strict quality and safety standards,” an FDA spokesman said in a statement.

Based on the FDA’s in-depth analysis and investigation of all 128 consumer complaints reported to the agency and recently released to the media in response to a FOIA request, only four complaints could be included in the case series in connection with the investigation. about Abbott Nutrition ”.

Abbott Nutrition said no causal link had been established between Abbott products and any of the reported deaths.

“Abbott performs microbiological tests on pre-distribution products, and no Abbott formulas distributed to consumers have tested positive for Cronobacter sakazakii or Salmonella. All canned products tested by Abbott and the FDA during plant inspection were negative for Cronobacter sakazakii and / or Salmonella. not found salmonella at the Sturgis plant, “the company said in a statement.

“There does not appear to have been a sense of urgency in the FDA to address the deteriorating situation at a production facility that in many cases was the sole source of nutrition for a vulnerable population,” said Phyllis Entis. , a food safety expert who first notified the complainants.

Attorney Sam Geisler represents over two dozen families who have claimed their children became ill after drinking Abbott’s formula.

He said the reports are evidence of systemic problems at the Sturgis plant.

“With each development, it becomes clearer and clearer that children were the last consideration of regulators and the company,” he said.

Centers for Disease Control and Prevention confirmed that the bacteria were present at the factory and performed tests, but it was not possible to determine the source of the infection – whether it was the formula or something else.

“The CDC has not been notified of any further cases received through the Consumer Complaints System at this time, and there are no pending tests related to this investigation,” said Brian Katzowitz, CDC Health Communications Specialist.

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The Sturgis factory reopened Saturday, and FDA investigators remained on the scene for several days to observe the plant.

“The crisis that has paralyzed parents’ ability across the country to find the formula they need to feed their children could have been avoided if the FDA had the resources and management structure to prioritize food safety,” said Scott Farber, senior Vice-President of Government Affairs for the Environment Working Group.

Abbott Nutrition said no salmonella was found in the plants

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The Sturgis factory was closed for five months before reopening on Saturday

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