FDA 483 - Octapharma Plasma, Inc. - February 17, 2022

Octapharma Plasma, Inc. in Whitehall, PA, a plasmapheresis center, was cited for significant quality control deficiencies during an FDA inspection. The firm failed to thoroughly investigate major deviations related to recurring red cell losses and minor deviation rate trends, with many corrective actions proving ineffective. Additionally, the company did not consistently follow its own written standard operating procedures for the timely initiation and closure of deviations and corrective and preventative actions.