FDA Lacked Inspection, Recall Plans in Infant Formula Shortage

The FDA had inadequate policies and procedures to identify risks to infant formula leading up to a shortage in 2022, according to an HHS Office of Inspector General report.

The Thursday report calls on the Food and Drug Administration to improve the safety of the infant formula supply following an audit conducted after the agency warned consumers in February 2022 not to use certain powdered infant formula products from Abbott Laboratories’ Sturgis, Mich., production facility.

Several consumer complaints and a whistleblower complaint alleged safety concerns at the facility, which prompted the FDA to conduct an inspection. Abbott voluntarily ceased production ...