A new report adds the Inspector General’s voice to the autopsy of America’s recent infant formula shortage. The Inspector General’s Office for the U.S.
Department of Health and Human Services has found the Food and Drug Administration (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, the IG found that the FDA had not developed an organizational structure or assigned responsibilities to handle whistleblower complaints efficiently and effectively and took more than 15 months to address a February 2021 Abbott facility whistleblower complaint. In addition, the IG said the FDA did not pass an October 2021 whistleblower complaint on to senior administrators, resulting in a nearly 4-month delay before top decision-makers were 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,“ it added. “Further, FDA did not have sufficient policies and procedures on initiating an infant formula recall under its FDA-required recall authority.” The IG recommends that the Food and Drug Administration: • prioritize maintaining the National Consumer Complaint Coordinator’s (NCCC’s) continuity of operations by cro.
