FDA 483 - Octapharma Plasma Inc - January 10, 2024

An FDA inspection of Octapharma Plasma Inc.'s plasmapheresis center in Cincinnati, OH, revealed a significant issue with adherence to written standard operating procedures. Specifically, employees failed to consistently follow procedures for visually inspecting refractometers for red blood cells during donor screening, potentially impacting the quality and safety of collected blood components. This indicates a breakdown in procedural compliance during critical donor evaluation steps.