The U.S. Department of Health and Human Services, Office of the Inspector General (OIG) has announced an audit of the FDA over its actions regarding the Abbott infant formula recall. The audit, announced on June 2, will “determine whether FDA followed the inspections and recall process for infant formula in accordance with Federal requirements.”
The OIG is specifically examining the FDA’s actions leading up to the infant formula recall at the Abbott facility in February 2022 to determine whether FDA followed applicable policies and procedures related to conducting inspections of the manufacturing facility and overseeing Abbott’s initiation of the infant formula recall.
The FDA released a timeline of its infant formula-related activities, showing that inspectors first became aware of issues including standing water and inadequate handwashing during a routine inspection at Abbott Nutrition’s Sturgis, Michigan, facility in September 2021—the same month that the FDA received the first consumer complaint report of Cronobacter illness in an infant from the Minnesota Department of Health.
One key area of frustration during Congressional hearings in May was the delay of action on a whistleblower report filed with the FDA Detroit District Office in October 2021. The complaint was not reviewed by FDA leadership until February 2002, “due to an isolated failure in FDA’s mailroom, likely due to COVID-19 staffing issues,” according to the FDA.
Additional inspections of the facility between January and March 2022 found “significant, fundamental sanitation, building and equipment issues.” Swabs taken during the inspections revealed six confirmed samples of Cronobacter. These findings led Abbott, on the recommendation of the FDA, to voluntarily cease production at the facility and recall potentially contaminated products. The contaminated formula has been linked to four hospitalizations and two deaths.
The OIG audit is scheduled to be completed in 2023.