The FDA Inspection and Recall Process should be improved to ensure the safety of the infant formula supply

The OIG (Office of Inspection General) stated that the 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. As a result, it took more than 15 months to address a February 2021 Abbott facility whistleblower complaint. Also, an October 2021 whistleblower complaint to senior leadership resulted in a nearly 4-month delay before senior leadership was aware of the complaint. The FDA did not have policies and procedures to establish timeframes to initiate mission-critical inspections. This contributed to one inspection being initiated 102 days after receiving a whistleblower complaint.OIG recommends to FDA: (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 promptly, and (4) design and implement policies and procedures specific to the use of its FDA-required infant formula recall authority. FDA concurred with all nine of our recommendations. @


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