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 plant that was at the center of a national shortage of infant formula, according to a new audit.
The Department of Labor received the email and forwarded it three days later to an FDA address specifically for such complaints. But one of several staff members responsible for managing the FDA’s inbox at the time “inadvertently archived” the email in February 2021, and it was not found until a reporter requested it in June 2022.
This episode is one of several conducted by the Department of Health and Human Services’ Office of Inspector General. to conclude in a report released Thursday, the FDA’s policies and procedures for addressing problems at the Abbott plant were inadequate.
The FDA took some actions and conducted follow-up inspections, but “more could have been done before the recall of Abbott’s powdered infant formula,” the auditors wrote. The FDA needs better policies to report the status of complaints to senior leadership and to ensure inspections are completed promptly, the report concludes.
“The key is that going forward, the FDA should do better and the American public should expect better,” Deputy Inspector General Carla Lewis said in an interview.
Several infants were hospitalized and two died from a rare bacterial infection after being fed powdered formula made at Abbott’s Michigan plant, the nation’s largest. The FDA shut down the site for several months from February 2022, and the company recalled several batches of popular formulas including Similac, Alimentum and EleCare.
FDA inspectors ultimately discovered 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 reveals that it took the FDA 102 days to inspect the plant after receiving another whistleblower complaint in October 2021. During that time, the agency received two complaints – one for illness and another for death – among infants who consumed herbal formula, but the formula samples were negative for Cronobacter, the bacteria in question.
The FDA said in a statement that it agreed with the inspector general’s findings. In its own 2022 report, the agency recognized that its response was slowed by delays in processing a whistleblower complaint and factory-tested samples.
“It should be noted that the OIG assessment represents a snapshot in time and FDA continues to make progress,” an FDA spokesperson said.
The FDA has established a “framework of critical foods investigators, which will focus solely on the inspection and oversight of the infant formula (and other critical foods) industry,” the spokesperson said. It also began improving how it tracks paper mailings, which may include complaints, the FDA said.
Dr. Steven Abrams, a professor of pediatrics at the University of Texas at Austin, said he agreed with the report’s recommendations, which include that Congress should give the FDA the authority to require manufacturers report any tests showing contamination of infant formula, even if the product does not. I’m not leaving the factory.
“Like anything else, mistakes were made. But the government is working very hard, including the FDA. It’s about filling the gaps that existed,” Abrams said. “People need to be comfortable with the safety of powdered infant formula. »
