FDA 483 - Wyeth Pharmaceutical Division of Wyeth Holdings LLC - October 17, 2024

An FDA inspection of Wyeth Pharmaceutical Division of Wyeth Holdings LLC in Sanford, NC, revealed a critical failure to thoroughly review unexplained discrepancies during drug substance manufacturing. Specifically, the firm did not properly investigate or document critical alarms related to pressure readings and flow rates for BEQVEZ (FidaVec) drug substance batches. Several affected batches were subsequently released by QA without a proper impact assessment, indicating a significant lapse in quality control.