FDA "inadvertently archived" complaint about Abbott infant formula plant, audit says [CBS News]
Abbott Laboratories (ABT)
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Source: CBS News
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 hospitalize
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- 5/10/24 - Form 144
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