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Audit Reveals Delayed FDA Response to Complaint About Abbott Infant Formula Factory

The U.S. Food and Drug Administration (FDA) faced criticism in a recent audit for its delayed response to a whistleblower’s concerns about conditions at an Abbott Nutrition factory, which contributed to a nationwide shortage of infant formula. The audit revealed that the FDA took over 15 months to address the complaint it received.

According to the audit, the Department of Labor initially received the whistleblower’s email and promptly forwarded it to an FDA address designated for such complaints. However, due to an oversight by FDA staff managing the inbox at the time, the email was mistakenly archived in February 2021 and was only rediscovered when a reporter requested it in June 2022.

These findings were part of a broader critique by the Department of Health and Human Services’ Office of Inspector General, which concluded that the FDA’s protocols for handling issues at the Abbott plant were insufficient. Although the FDA undertook some actions and conducted follow-up inspections, auditors noted that more proactive measures could have been taken before the eventual recall of Abbott powdered infant formula.

Assistant Inspector General Carla Lewis emphasized the need for improved FDA policies to promptly report complaint statuses to senior leadership and ensure swift inspections. She highlighted the importance of future improvements, stating, “Moving forward, FDA should be doing better, and the American public should expect better.”

The audit also highlighted specific incidents, including hospitalizations and fatalities of infants due to a rare bacterial infection linked to the Abbott plant’s powdered formula. While the FDA temporarily closed the facility and issued recalls, investigators found several violations, including bacterial contamination and inadequate safety protocols. However, no direct link was established between the infections and the formula.

Moreover, the audit revealed significant delays in FDA inspections following another whistleblower complaint in October 2021, despite reports of illnesses and a death among infants who consumed formula from the plant. Although formula samples tested negative for the bacteria in question, the FDA took 102 days to conduct an inspection.

In response to the audit, the FDA acknowledged shortcomings in its response time, attributing delays to processing issues with whistleblower complaints and factory test samples. The agency affirmed its commitment to ongoing improvements, including the establishment of a specialized “critical foods investigator cadre” focused on enhancing oversight of the infant formula industry.

Dr. Steven Abrams, a pediatrics professor at the University of Texas at Austin, supported the audit’s recommendations, particularly endorsing the idea that Congress should empower the FDA to mandate reporting of any infant formula contamination test results, regardless of whether the product has left the factory.

Reflecting on the audit’s findings, Dr. Abrams acknowledged past mistakes but expressed confidence in ongoing efforts by the FDA and government to address gaps and ensure the safety of powdered infant formula.

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