A new audit shows that the U.S. Food and Drug Administration (FDA) took more than 15 months to act on a whistleblower complaint about conditions at an Abbott Nutrition factory. This factory was at the center of a nationwide shortage of infant formula.
The Department of Labor received the email complaint and forwarded it to a specific FDA address for such complaints three days later. However, one of the FDA staff members responsible for managing the inbox at the time accidentally archived the email in February 2021. The email wasn’t found until a reporter requested it in June 2022.
This is one of several issues that led the Department of Health and Human Services’ Office of Inspector General to conclude in a report that the FDA’s policies and procedures for addressing the problems at the Abbott plant were not good enough.
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,” according to the auditors. The report concluded that the FDA needs better policies for reporting the status of complaints to senior leaders and ensuring that inspections are done quickly.
“The key is, moving forward, FDA should be doing better, and the American public should expect better,” said Assistant Inspector General Carla Lewis.
Several infants were hospitalized, and two died from a rare bacterial infection after being fed the powdered formula made at Abbott’s Michigan plant, the nation’s largest. The FDA closed the site for several months starting in February 2022, and the company recalled several popular formula brands, including Similac, Alimentum, and EleCare.
FDA inspectors eventually found many violations at the plant, including bacterial contamination, a leaky roof, and lax safety protocols. However, the agency never found a direct link between the infections and the formula.
The new report also found that it took 102 days for the FDA to inspect the factory after receiving a different whistleblower complaint in October 2021. During 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 tested 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 has established a “critical foods investigator cadre,” which will focus solely on the inspection and oversight of the infant formula (and other critical foods) industry. It has also started improving how it tracks hard-copy mail items, which can include complaints.
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 to 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.”
The Associated Press contributed to this article.