A new audit shows it took the U.S. Food and Drug Administration more than 15 months to act on reports it received about conditions at an Abbott Nutrition plant that is the center of a national infant formula shortage.
The Labor Department received the email and three days later forwarded it to the FDA’s address specifically for such complaints. But one of several staff members responsible for managing the FDA’s inbox at the time “accidentally archived” the email in February 2021, and the email was not found until a reporter requested it in June 2022.
The incident is one of several in which the U.S. Department of Health and Human Services’ Office of Inspector General concluded in a report Thursday that 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 Abbott’s infant formula was recalled,” auditors wrote. The report concluded that the FDA needs better policies for reporting complaint status to senior leadership and ensuring inspections are completed quickly.
“The point is, moving forward, the FDA should do better and the American public should expect better,” Assistant Inspector General Kara Lewis said in an interview.
Several babies have been hospitalized and two have died with rare bacterial infections after consuming formula produced at Abbott’s Michigan plant, the largest in the United States. The FDA shut down the site for several months starting in February 2022, and the company also recalled several popular formulas, including Similac, Alimentum and EleCare.
FDA inspectors eventually found a series 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 that the FDA took 102 days to inspect the plant after receiving another whistleblower complaint in October 2021. While one resulted in illness, the other was death.
The FDA said in a statement that it agreed with the inspector general’s conclusions. The agency acknowledged in its 2022 report that its response was slowed by delays in processing whistleblowers and factory testing samples.
“It should be noted that the OIG’s assessment is only a snapshot in time, and FDA continues to make progress,” an FDA spokesperson said.
The spokesperson said the FDA has established a “critical food investigator team specifically responsible for the inspection and supervision of the infant formula (and other critical food) industry.” The FDA said it is also starting to improve how it tracks hard-copy mailings, which can include complaints.
Dr. Steven Abrams, a professor of pediatrics at the University of Texas at Austin, said he agreed with the report’s recommendations, including that Congress should give the FDA the power to require manufacturers to report any tests showing contamination in infant formula, even if the product No one is allowed to leave the factory.
“Like anything else, there were some mistakes made. But the government is working very hard, including the FDA. It’s closing the gaps that exist,” Abrams said. “People have to be satisfied that infant formula is safe.”
