FDA 483 - Apotex Inc. - April 28, 2025

An FDA inspection conducted from April 28 to May 9, 2025, at Apotex Inc. revealed significant concerns regarding quality control and investigation processes. The primary issues observed included a systemic failure to thoroughly review unexplained discrepancies and instances where products or components did not meet specifications, particularly concerning aseptic manufacturing. Specifically, the inspection highlighted numerous undocumented failures of leak tests on aseptic filling lines, including a recent event on April 30, 2025, where 34 leaking locations were identified on a critical filling line. Past leak test failures, dating back to 2023, were also cited for lacking comprehensive investigations into their root cause or impact on previously produced sterile drug products. Furthermore, the company"s approach to investigating anomalous individual bottle weight loss results during stability testing was found deficient. These investigations failed to assess if such results indicated compromised product integrity or to determine their impact on commercial batches. These observations underscore a lack of adherence to current Good Manufacturing Practices (cGMPs), indicating a need for Apotex Inc. to implement robust corrective actions. These actions must ensure all discrepancies are thoroughly documented and investigated, their root causes determined, and the potential impact on product quality and patient safety is comprehensively assessed for all affected batches.