OIG

The Food and Drug Administration’s Inspection and Recall Process Should Be Improved To Ensure the Safety of the Infant Formula Supply

What OIG Found

FDA had inadequate policies and procedures or lacked policies and procedures to identify risks to infant formula and respond effectively through its complaint, inspection, and recall processes. For example, FDA had not developed an organizational structure or assigned responsibilities to handle whistleblower complaints in an efficient and effective manner and took more than 15 months to address a February 2021 Abbott facility whistleblower complaint. In addition, FDA did not escalate an October 2021 whistleblower complaint to senior leadership, resulting in a nearly 4-month delay before senior leadership was aware of the complaint. We also found that FDA did not have policies and procedures to establish timeframes for the initiation of mission-critical inspections, which contributed to one inspection being initiated 102 days after a whistleblower complaint was received. Further, FDA did not have sufficient policies and procedures on how to initiate an infant formula recall under its FDA-required recall authority.

What OIG Recommends

We made nine recommendations to FDA, including that it: (1) maintain the National Consumer Complaint Coordinator’s (NCCC’s) continuity of operations by cross-training staff on whistleblower policies and procedures and NCCC duties, (2) develop and implement policies and procedures requiring periodic reporting to senior leadership on the status of open whistleblower complaints, (3) 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 they are conducted in a timely manner, and (4) design and implement policies and procedures specific to the use of its FDA-required infant formula recall authority. The full recommendations are in the report. FDA concurred with all nine of our recommendations.

Findings

  • FDA did not have adequate policies and procedures or lacked policies and procedure
  • FDA did not have adequate policies and procedures to identify the February 2021 Whistleblower Complaint
  • FDA did not have adequate policies and procedures to escalate to the October 2021 Whistleblower Complaint
  • FDA did not have adequate policies and procedures to communicate consumer complaints to investigators
  • FDA did not have adequate policies and procedures to identify and correct infant formula consumer complaint data inaccuracies
  • FDA policies and procedures did not identify specific factors to determine which adverse event complaints should be communicated to the NCCC
  • FDA did not have policies and procedures to establish timeframes for the initiation of mission-critical inspections
  • FDA did not have adequate policies and procedures for initiating an FDA-required recall
  • FDA did not have the authority to require individuals and manufacturers to provide information that may have helped FDA to identify and respond to risks in the infant formula supply

See full report – https://oig.hhs.gov/documents/audit/9908/A-01-22-01502.pdf