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The FDA in February said two babies died potentially from bacteria linked to infant formula.
Abbott Nutrition recalled lots of some formulas made in their Sturgis, Michigan, plant.
Rep. Rosa DeLauro on Thursday said a whistleblower alerted the FDA to the plant in October.
A whistleblower notified the Food and Drug Administration about concerns with a plant that produces infant formula months before two babies died and the products were recalled, according to a newly revealed document.
The FDA said in February it was investigating reports of bacterial infections related to powdered infant formula made at Abbott Nutrition’s plant in Sturgis, Michigan. Abbott Nutrition recalled select lots of its Similac, Alimentum, and EleCare formulas.
The FDA said two deaths had been reported and that a “Cronobacter infection may have contributed to the cause of death for both patients.”
In mid-October, months before the deaths and recalls, a whistleblower sent the FDA a 34-page document outlining potential concerns with the Sturgis plant, Rep. Rosa DeLauro revealed in a statement on Thursday.
The document, written by a former plant employee, accused the plant of lax cleaning practices, falsifying records, releasing untested infant formula, and hiding information during an FDA audit in 2019, among other issues.
“I am deeply concerned about the practices at this Abbott facility and their apparent failure to implement and enforce internal controls at this facility,” DeLauro said in the statement, adding: “I am equally concerned that the FDA reacted far too slowly to this report.”
“Why did the FDA not spring into action?” she said. “Why did it take four months to pull this formula off store shelves? How many infants were fed contaminated formula during this time?”
In a statement to Insider, the FDA acknowledged “there have been questions about the timeline related to the Abbott Nutrition infant formula recall.”
“However, this remains an open investigation with many moving parts. Our top priority is ensuring that any recalled product produced at the Sturgis, Mich. facility has been removed from the market,” the statement said. “We are continuing to investigate and will continue to update our consumer alert should additional consumer safety information become available.”
Abbott Nutrition did not immediately respond to Insider’s request for comment, but previously told CNN: “We value the trust parents place in us for high quality and safe nutrition and we’ll do whatever it takes to keep that trust.”
The recalls have also contributed to recent shortages in infant …read more
Source:: Business Insider