The U.S. Food and Drug Administration took more than 15 months to respond to a whistle-blower complaint about working conditions at an Abbott Nutrition factory that was at the center of a nationwide infant formula shortage, according to a new audit.
The Department of Labor received the email and forwarded it three days later to an FDA address dedicated to such complaints, but one of several employees responsible for managing the FDA’s inbox at the time “inadvertently archived” it in February 2021, and the email was never found until a reporter requested it in June 2022.
The case was investigated by the Department of Health and Human Services’ Office of Inspector General. in conclusion The FDA reported Thursday that policies and procedures for addressing problems at the Abbott plant were inadequate.
While the FDA took some steps and conducted follow-up inspections, “more could have been done before Abbott’s recall of infant formula,” the auditors wrote. The FDA needs better policies for escalating complaints to senior management and ensuring inspections are carried out promptly, the report concluded.
“The bottom line is that going forward, the FDA should do better and the American people should expect better,” Assistant Inspector General Carla Lewis said in an interview.
The FDA has shut down Abbott’s Michigan plant, the nation’s largest, after several babies were hospitalized with a rare bacterial infection and two died after drinking formula made at the plant. A few months Starting in February 2022, the company Some lots recalled Popular formulas like Similac, Alimentum, and Elecare.
FDA inspectors ultimately found numerous violations at the plant, including bacterial contamination, a leaking roof, and poor safety practices, but the FDA was unable to find a direct link between the infections and manufacturing processes.
The new report also found that it took the FDA 102 days to inspect the plant after receiving another whistleblower complaint in October 2021. During that time, the FDA received two complaints of illness and death among infants who drank formula made at the plant, but samples of the formula 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 FDA said: The authorities acknowledged It said delays in processing whistleblower complaints and factory test samples led to a delayed response.
“It is important to note that the OIG’s assessment represents a point in time and the FDA continues to make progress,” an FDA spokesperson said.
The FDA has established “a body of critical food inspectors dedicated to inspecting and oversight of the infant formula (and other critical foods) industry,” a spokesperson said. The agency has also begun improving how it tracks paper mailings that may contain complaints, the FDA said.
Dr. Steven Abrams, a professor of pediatrics at the University of Texas at Austin, said he agrees with the report’s recommendations, including that Congress should give the FDA the authority to require manufacturers to report test results that show contaminated infant formula, even if the product has not left the factory.
“Like anything, mistakes were made, but the government, including the FDA, is working hard to fix the flaws that existed,” Abrams said. “People should feel reassured that infant formula is safe.”
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AP Health Reporter Jonel Alesia contributed to this report.
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