FDA's Delayed Response to Complaints at Abbott Nutrition Factory on Manufacture of Infant Formula

A current audit discloses that the U.S. Food and Drug Administration took over 15 months to answer a whistleblower complaint concerning situations at an Abbott Nutrition factory, which played a central role in a nationwide scarcity of infant formula.

FDA Responded to Complaints at Abbott Nutrition Factory

The Department of Labor obtained the email and forwarded it to an FDA address designated for such complaints three days later.

However, one of the staff members accountable for managing the FDA inbox negligently archived the email in February 2021, and it remained unseen until a reporter requested it in June 2022.

These circumstances, among others, led the Office of Inspector General of the Department of Health and Human Services to conclude in a report issued Thursday that the FDA's policies and procedures for addressing concerns at the Abbott plant were insufficient.

While the FDA did take some actions and administered follow-up inspections, auditors noted that more proactive measures could have been taken prior to the recall of Abbott powdered infant formula.

The audit concluded that the FDA needs improved policies for promptly reporting complaint statuses to senior leaders and ensuring timely inspections.

Assistant Inspector General Carla Lewis highlighted in an interview that going forward, the FDA needs to enhance its performance, and the public should anticipate higher standards.

The Abbott Nutrition factory in Michigan, the largest in the country, saw several infants hospitalized and two fatalities due to a rare bacterial infection connected to its powdered formula.

Following these circumstances, the FDA closed the facility for several months starting in February 2022, and Abbott subsequently recalled several batches of popular formulas like Similac, Alimentum, and EleCare.

FDA Inspectors Identified Several Violations at the Facility

Although FDA inspectors later discovered numerous violations at the plant, including bacterial contamination, roof leaks, and inadequate safety protocols, the agency did not establish a direct connection between the infections and the formula.

The new audit also revealed that it took the FDA 102 days to inspect the factory after receiving a different whistleblower complaint in October 2021.

During this period, the agency received reports of an illness and a death among infants who had consumed formula from the plant, although tests on formula samples did not detect cronobacter, the bacteria in question.

In response to the inspector general's findings, the FDA stated that it concurred with the conclusions. The agency's own 2022 report acknowledged that its response was hindered by delays in processing the whistleblower complaint and factory test samples.

An FDA spokesperson noted, "It should be emphasized that the OIG's assessment reflects a specific point in time, and the FDA continues to make advancements."

The FDA has established a specialized team of "critical foods investigators" dedicated to overseeing the infant formula industry and other critical foods.

Additionally, the agency has begun enhancing its methods for tracking physical mail items, which may include complaints.

Dr. Steven Abrams, a pediatrics professor at the University of Texas at Austin, agreed with the report's recommendations, including the suggestion that Congress empower the FDA to mandate manufacturers report any instance of infant formula contamination detected during testing, regardless of whether the product has left the factory.

Abrams acknowledged past shortcomings but emphasized ongoing efforts by the government and the FDA to address these gaps. He added, "People need assurance regarding the safety of powdered infant formula."