The FDA lost a whistleblower complaint about unsanitary conditions at an infant formula plant for a year, auditors revealed [Fortune]
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Abbott Laboratories (ABT)
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Source: Fortune
factory that was at the center of a nationwide shortage of infant formula, a new audit shows. The Department of Labor received the email and three days later forwarded it to an FDA address specifically for such complaints. But one of several staff members charged with managing the FDA inbox at the time “inadvertently archived” the email in February 2021, and it wasn't found until a reporter requested it in June 2022. The episode is one of several that led the Department of Health and Human Services' Office of Inspector General to conclude in a report Thursday that the FDA's policies and procedures to address the issues at the Abbott plant were inadequate. The FDA took some actions and did follow-up inspections but “more could have been done leading up to the Abbott powdered infant formula recall,” the auditors wrote. The FDA needs better policies for reporting the status of complaints to senior leaders and to make sure that inspections are done quickly, the report concluded. “
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