FDA

The Food and Drug Administration “inadvertently archived” a whistleblower’s complaint regarding conditions at an Abbott Nutrition plant that produced powdered baby formula recalled in 2022 due to bacteria that killed two infants, an audit shows.

An early 2021 email raised red flags about the plant in Sturgis, Michigan, that became the focal point of a nationwide shortage of infant formula when it was temporarily shuttered 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 report.

“More could have been done leading up to the Abbott powdered infant formula recall,” noted the auditor. 

It took 102 days for the FDA to inspect the plant after getting a separate whistleblower complaint in October 2021. During those months, the FDA received two complaints, one of an illness and the second a death, of infants who consumed formula from the facility. Yet samples tested negative for Cronobacter sakazakii, the bacteria in question. 

Several infants were hospitalized and two died of a rare bacterial infection after drinking the powdered formula made at Abbott’s Sturgis factory, the nation’s largest. The FDA closed the plant for several months beginning in February 2022, and well-known formulas including Alimentum, EleCare and Similac were recalled.

FDA inspectors eventually found violations at the factory including bacterial contamination, a leaky roof and lax safety practices, but the agency never found a direct connection between the infections and the formula. 

The FDA concurred with the report’s findings, but noted it was making progress to address the issues behind delays in processing complaints and testing factory samples. 

Dr. Steven Abrams, a pediatrics professor at the University of Texas at Austin, agreed with the report’s recommendations, including that Congress should empower the FDA to require manufacturers to report any test showing infant formula contamination, even if the product doesn’t leave the factory.

“Like anything else, there were mistakes made. But the government is working very hard, including the FDA. It’s fixing the gaps that existed,” Abrams told the Associated Press. “People have to be comfortable with the safety of powdered infant formula.”

Separately, recalls of infant formula from varied sources have continued. 

In January, 675,030 cans of Reckitt/Mead Johnson Nutrition’s infant formula sold in the U.S. were recalled after health authorities confirmed cronobacter was found in cans imported into Israel from the U.S. 

More recently, a Texas firm earlier this month expanded its recall of Crecelac, a powdered goat milk infant formula, after finding a sample contaminated with cronobacter.

—The Associated Press contributed to this report.