William Simpson
The Food and Drug Administration “inadvertently filed” a whistleblower complaint about conditions at an Abbott Nutrition plant that produced powdered baby formula recalled in 2022 due to a bacteria that killed two children, an audit shows.
An early 2021 email raised warning signs about the plant in Sturgis, Michigan, which became the focal point of a national infant formula shortage when it was temporarily closed the following year.
An FDA employee “inadvertently archived” the email, which resurfaced when a reporter requested it in June 2022, the U.S. Department of Health and Human Services Office of Inspector General said Thursday in a statement. report.
“More could have been done before the Abbott powdered infant formula recall,” the auditor noted.
It took 102 days for the FDA to inspect the plant after receiving a separate whistleblower complaint in October 2021. During those months, the FDA received two complaints, one of illness and the second of death, from babies who consumed formula from the facility. However, the samples tested negative for Cronobacter sakazakii, the bacteria in question.
Several children were hospitalized and two died from a rare bacterial infection after drinking the powdered formula made in The Abbott plant in Sturgis, the largest in the country. The FDA closed the plant for several months beginning in February 2022, and well-known formulas including Alimentum, EleCare, and Similac were removed from the market.
FDA inspectors eventually found violations at the factory, including bacterial contamination, a leaking roof and lax safety practices, but the agency never found a direct connection between the infections and the formula.
The FDA agreed with the report’s conclusions, but noted that it was making progress to address problems behind delays in processing claims and testing factory samples.
Steven Abrams, a professor of pediatrics at the University of Texas at Austin, agreed with the report’s recommendations, including that Congress should authorize the FDA to require manufacturers to report any testing that shows contamination of infant formula, even if the product does not leave the Marketplace. factory.
“Like anything else, mistakes were made. But the government is working very hard, including the FDA. It’s correcting the gaps that were there,” Abrams told the Associated Press. “People need to be comfortable with the safety of powdered infant formula.”
Separately, infant formula recalls from varied sources continued.
In January, 675,030 cans of Reckitt/Mead Johnson Nutrition infant formula sold in the US were recalled after health authorities confirmed that cronobacter was found in cans imported from the US to Israel
More recently, a Texas company earlier this month expanded its to remember of Crecelac, a powdered goat’s milk infant formula, after finding a sample contaminated with cronobacter.
—The Associated Press contributed to this report.
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