Food and Drug Administration's Actions Regarding the Abbott Infant Formula Recall

The Federal Food, Drug, and Cosmetic Act requires the Food and Drug Administration (FDA) to safeguard the Nation's food supply, including infant formula, and ensure that all ingredients are safe. As part of its oversight activities, FDA conducts inspections at infant formula manufacturers and can require infant formula manufacturers to recall adulterated infant formula that presents a risk to human health. We will determine whether FDA followed the inspections and recall process for infant formula in accordance with Federal requirements. Specifically, we will review 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 to: (1) conduct inspections of the manufacturing facility and (2) oversee Abbott's initiation of the infant formula recall.

Announced or Revised	Agency	Title	Component	Report Number(s)	Expected Issue Date (FY)
Completed	Food and Drug Administration	Food and Drug Administration's Actions Regarding the Abbott Infant Formula Recall	Office of Audit Services	WA-22-0006 (W-00-22-59472); A-01-22-01502	2024