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 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 whistleblower complaint and factory test samples.
“It should be noted that the OIG’s evaluation represents a snapshot in time, and the FDA continues to make progress,” an FDA spokesperson said.
The FDA established a “critical foods investigator cadre, which will solely focus on the inspection and oversight of the infant formula (and other critical foods) industry,” the spokesperson said. It also started improving how it tracks hard-copy mail items, which can include complaints, the FDA said.
Dr. Steven Abrams, a pediatrics professor at the University of Texas at Austin, said he agreed with the report’s recommendations, which include that Congress should give the FDA the power to require manufacturers report any test showing infant formula contamination, even if the product doesn’t leave the factory.
“Like anything else, there were mistakes made. But the government is working very hard, including the FDA. It’s fixing the gaps that existed,” Abrams said. “People have to be comfortable with the safety of powdered infant formula.”
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