The FDA lost a whistleblower complaint about unsanitary conditions at an infant formula plant for a year, auditors revealed

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 powdered 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 recalled several lots of popular formulas including Similac, Alimentum and EleCare.

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.

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 — one of an illness and another of a death — among infants who consumed formula from the plant, but formula samples were negative for cronobacter, the bacteria in question.

The FDA said in a statement that it agreed with the inspector general’s conclusions. In its own 2022 report, the agency acknowledged that its response was slowed by delays in processing a…