The Food and Drug Administration “accidentally” archived a whistleblower’s complaint about conditions at an Abbott Nutrition plant that produced powdered baby food that was recalled in 2022 due to bacteria that killed two babies, an audit has found.
An email from early 2021 raised red flags about the Sturgis, Michigan, plant, which became the focal point of a nationwide infant formula shortage when it temporarily closed the following year.
An FDA employee “accidentally 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 in a report Thursday.
“More could have been done in the lead-up to the recall of Abbott’s powdered infant formula,” 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 using formula from the factory. Still, the samples tested negative for Cronobacter sakazakii, the bacterium in question.
Several babies were hospitalized and two died from a rare bacterial infection after drinking the powdered formula Abbott’s Sturgis plant, the largest in the country. The FDA closed the plant for several months starting in February 2022 and well-known formulas including Alimentum, EleCare and Similac were recalled.
FDA inspectors eventually discovered violations at the plant, including bacterial contamination, a leaky roof and lax safety practices, but the agency never found a direct link between the infections and the formula.
The FDA agreed with the report’s findings, but noted that it was making progress in addressing the problems behind delays in processing complaints and testing factory samples.
Dr. Steven Abrams, a professor of pediatrics at the University of Texas at Austin, agreed with the report’s recommendations, including that Congress should give the FDA the authority to require manufacturers to report any test that shows contamination of infant formula, even if the product does not leave the factory. factory.
“Like anything else, mistakes have been made. But the government is working very hard, including the FDA. They are fixing the gaps that exist,” Abrams told the Associated Press. “People need to feel comfortable with the safety of powdered infant formula.”
Individual, infant formula recalls from various sources have been continued.
In January, 675,030 cans of Reckitt/Mead Johnson Nutrition’s infant formula sold in the US were recalled after health authorities confirmed that cronobacter had been found in cans imported into Israel from the US
More recently, a Texas company expanded its recall of Crecelac, a powdered goat’s milk infant formula, earlier this month after finding a sample contaminated with cronobacter.
—The Associated Press contributed to this report.
