FDA 483 - Octapharma Plasma Inc - March 24, 2022

An FDA inspection of Octapharma Plasma Inc in Baton Rouge, LA, a source plasma center, revealed a significant failure to perform thorough investigations into unexplained discrepancies. The firm consistently failed to identify root causes and implement effective corrective and preventative actions for recurring issues, including high red blood cell loss rates and minor deviation error rates over an extended period. This indicates a systemic weakness in the firm's quality management and deviation investigation processes.