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

Announced on  | Last Modified on  | Project Number: A-01-22-01502
Status
Completed
Agency
Food and Drug Administration

OBJECTIVE

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.

TIMELINE

  • June 2, 2022
    Announced
  • June 10, 2024
    Complete

    Audit of the Food and Drug Administration's Actions Regarding the Abbott Infant Formula Recall has been marked as complete. This audit resulted in 9 recommendations.

REPORT PUBLISHED

The Food and Drug Administration’s Inspection and Recall Process Should Be Improved To Ensure the Safety of the Infant Formula Supply (A-01-22-01502)

24-A-01-080.01 to FDA - Closed Implemented
Closed on 04/28/2025
We recommend that the Food and Drug Administration prioritize maintaining the NCCC's continuity of operations by cross-training staff on whistleblower policies and procedures and NCCC duties, including monitoring the Occupational Safety and Health Administration whistleblower email inbox.

24-A-01-080.02 to FDA - Closed Implemented
Closed on 01/30/2025
We recommend that the Food and Drug Administration develop and implement policies and procedures requiring periodic reporting (e.g.,monthly reporting) to senior leadership on the status of open whistleblower complaints.

24-A-01-080.03 to FDA - Closed Implemented
Closed on 09/16/2025
We recommend that the Food and Drug Administration implement policies and procedures that facilitate reporting consumer complaints in real time to investigators onsite when an active inspection is occurring at the facility identified in the complaint.

24-A-01-080.04 to FDA - Closed Implemented
Closed on 01/30/2025
We recommend that the Food and Drug Administration strengthen the QFC process to identify data entry inaccuracies.

24-A-01-080.05 to FDA - Closed Acceptable Alternative
Closed on 12/19/2024
We recommend that the Food and Drug Administration formalize written policies and procedures that either require that the CAERS coordinator forward all reports that originate in CAERS to the NCCC or identify specific factors that the CAERS coordinator must consider when determining if adverse event reports should be forwarded to the NCCC, and include specific examples of types of adverse event reports that do not need to be forwarded to the NCCC.

24-A-01-080.06 to FDA - Open Unimplemented
Update expected on 06/19/2025
We recommend that the Food and Drug Administration develop policies and procedures that FDA can use during future public health emergencies to identify how and when it is necessary to conduct mission-critical inspections and ensure that mission-critical inspections are conducted in a timely manner.

24-A-01-080.07 to FDA - Open Unimplemented
Update expected on 06/19/2025
We recommend that the Food and Drug Administration design and implement policies and procedures specific to the use of its FDA-required infant formula recall authority.

24-A-01-080.08 to FDA - Closed Implemented
Closed on 12/19/2024
We recommend that the Food and Drug Administration amend the language on the CAERS adverse event report form to emphasize the importance of including the lot number to encourage the public to report this information.

24-A-01-080.09 to FDA - Closed Implemented
Closed on 01/30/2025
We recommend that the Food and Drug Administration continue to seek legislative authority to require infant formula manufacturers to notify and provide the bacterial isolate to FDA every time a product sample is found to be positive for Cronobacter or Salmonella, even if the affected lots have not been distributed, and update its existing databases with the information received.

View in Recommendation Tracker
Work Plan Type
Office of Audit Services
HHS Agencies
Food and Drug Administration
Issue Areas
Public Health Issues
Target Groups
Children and Families
Financial Groups
Other Funding