Washington

It took more than 15 months for the US Food and Drug Administration to act on it. whistleblower complaint A new audit shows she received information about conditions at the Abbott Nutrition factory that was at the center of a nationwide shortage of infant formula.

The Labor Department received this email and three days later it was forwarded to another person. FDA Such complaints are specifically addressed. But one of several employees managing the FDA inbox at the time “accidentally” archived the email in February 2021, and it wasn’t found until a reporter requested it in June 2022.

This incident is one of many that led to Department of Health and Human Services’ The inspector general’s office concluded in a report Thursday that the FDA’s policies and procedures were inadequate to address the problems at the Abbott plant.

FDA took some actions and follow-up inspection But “more could have been done for Abbott Powder Infant formula recall”The FDA needs better policies for notifying senior officials about the status of complaints and for ensuring that inspections are conducted promptly,” the auditors wrote, the report concluded.

“The important thing is that moving forward, the FDA must do better, and the American public should expect better, too,” Assistant Inspector General Carla Lewis said in an interview.

Several infants were hospitalised, two of whom died from the rare disease. bacterial infection After being fed powdered formula made at Abbott’s Michigan plant, one of the largest in the country, the FDA shut down the site for several months beginning in February 2022, and the company recalled several popular formulas, including Similac, Alimentum, and Elecare.

FDA inspectors eventually discovered numerous violations at the plant, including bacterial contamination, a leaky roof and lax safety protocols, but the agency found no 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 separate whistleblower complaint in October 2021. In that time, the agency received two complaints — one of illness and another of death — among infants eating formula from the plant, but samples of the formula 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 2022 report, the agency acknowledged that its response was slowed by delays in acting on a whistleblower complaint and factory test samples.

An FDA spokesperson said, “It should be noted that the OIG’s evaluation represents a snapshot in time, and the FDA is making ongoing progress.”

The FDA has a “Important Food Items Investigator CadreThe spokesperson said, “It will focus solely on inspection and monitoring of the infant formula (and other critical foods) industry.” The FDA said it has also begun improving the way it tracks hard-copy mail items, which can also contain 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 authority to require manufacturers to report any tests showing infant formula contamination, even after the product has left the factory.

“Like anything else, there have been mistakes. But the government, including the FDA, is working very hard. It’s closing the loopholes that exist,” Abrams said. “People should be comfortable about the safety of powdered infant formula.”

Health writer Jonelle Alesia contributed to this report.

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