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.
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.
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.
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