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The U.S. Food and Drug Administration took more than 15 months to act on a whistleblower complaint it received about conditions at an Abbott Nutrition factory that was at the center of a nationwide shortage of infant formula, a new audit shows.<\/p>\n
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 \u201cinadvertently archived\u201d the email in February 2021, and it wasn\u2019t found until a reporter requested it in June 2022.<\/p>\n
The episode is one of several that led the Department of Health and Human Services\u2019 Office of Inspector General\u00a0to conclude<\/a>\u00a0in a report Thursday that the FDA\u2019s policies and procedures to address the issues at the Abbott plant were inadequate.<\/p>\n The FDA took some actions and did follow-up inspections but \u201cmore could have been done leading up to the Abbott powdered infant formula recall,\u201d 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.<\/p>\n \u201cThe key is, moving forward, FDA should be doing better, and the American public should expect better,\u201d Assistant Inspector General Carla Lewis said in an interview.<\/p>\n Several infants were hospitalized, and two died, of a rare bacterial infection after being fed the powdered formula made at Abbott\u2019s Michigan plant, the nation\u2019s largest. The FDA shuttered the site\u00a0for several months<\/a>\u00a0starting in February 2022, and the company\u00a0recalled several lots<\/a>\u00a0of popular formulas including Similac, Alimentum and EleCare.<\/p>\n FDA inspectors eventually uncovered a host of violations at the plant, including bacterial contamination, a leaky roof and lax safety protocols, but the agency never found a direct link between the infections and the formula.<\/p>\n The new report also found it took 102 days for the FDA to inspect the factory after receiving a different whistleblower complaint in October 2021. In that time, the agency received two complaints \u2014 one of an illness and another of a death \u2014 among infants who consumed formula from the plant, but formula samples were negative for cronobacter, the bacteria in question.<\/p>\n