The Food and Drug Administration (FDA) was dangerously slow to respond to multiple complaints about conditions at an Abbott Nutrition facility that contributed to a nationwide infant formula shortage in 2022, according to a government watchdog report.
FDA did not have adequate — and in some cases completely lacked — policies and procedures to identify risks to infant formula and then respond to those risks effectively, the report from the Department of Health and Human Services’ Office of Inspector General (OIG) found.
For instance, the agency took more than 15 months to act on a whistleblower complaint about dangerous conditions at the Abbott plant that was first filed in February 2021.
The Department of Labor received the complaint and forwarded it to FDA three days later, but FDA did not identify the complaint until June 7, 2022.
“The complaint alleged that the Abbott facility engaged in practices that violated laws, regulations, and other guidance that FDA administered and enforced,” the report said.
“At the time of the initial submission of the February 2021 whistleblower complaint, FDA did not have adequate policies and procedures for identifying and investigating whistleblower complaints received in the dedicated FDA email inbox.”
The agency received a second warning from the same whistleblower several months later, in October 2021.
But according to the report, FDA “did not escalate [the October 2021] whistleblower complaint to senior leadership, resulting in a nearly 4-month delay before senior leadership was aware of the complaint.”
The agency eventually conducted inspections which uncovered a host of problems at the plant, but it took more than 100 days from the October whistleblower complaint to inspect the factory.
During the time it was waiting to inspect the plant, the agency received two consumer complaints about infants who consumed formula manufactured there. One was of an illness and one of a death, both from cronobacter — but formula samples were negative.
The inspection found unsanitary conditions, a leaky roof, lax safety practices and multiple strains of a bacteria that can be deadly to infants.
Several infants became ill and two died from a rare bacterial infection after being fed powdered formula that was manufactured at the plant. But the agency was unable to definitively link the infections to the formula.
FDA took some action during the facility inspections and conducted follow-up inspections, but “more could have been done leading up to the Abbott powdered infant formula recall,” the OIG report said.
FDA shuttered the plant for several months and the company issued a nationwide recall for all brands of powdered formula that had been manufactured at the facility, including popular brands like Alimentum, EleCare and Similac
Just four companies are responsible for 90 percent of the formula market. When Abbott’s plant shut down, the effects cascaded across a supply chain that was already strained because of the pandemic, causing a nationwide shortage.
The report noted FDA did not have the authority to require individuals and manufacturers to provide information that may have helped the agency to identify and respond to risks to the infant formula supply.
“If FDA had adequate policies and procedures and authority to obtain information, it could have identified underlying problems at the Abbott facility and required Abbott to correct them,” the report found.
FDA said it “strongly agrees that adequate policies, procedures, and authorities are needed, and that delays due to poor procedures are unacceptable and must be corrected.” The agency added it agreed with all the recommendations and has begun several steps to improve policies and procedures for complaints, recalls and infant formula inspections.
