FDA took months to react to complaint about Abbott infant formula factory, audit finds

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The U.S. Food and Drug Administration took 15 months to act on a whistleblower complaint about the Abbott Nutrition factory at the center 2022's nationwide infant formula shortage

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.

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.

“The key is, moving forward, FDA should be doing better, and the American public should expect better,” Assistant Inspector General Carla Lewis said in an interview.

Several infants were hospitalized, and two died, of a rare bacterial infection after being fed the powered formula made at Abbott's Michigan plant, the nation's largest. The FDA shuttered the site for several months starting in February 2022, and the company