FDA 483 - Octapharma Plasma, Inc. - November 19, 2021

An FDA inspection of Octapharma Plasma, Inc.'s plasmapheresis facility in San Pablo, CA, revealed significant deficiencies in quality control and record-keeping. Observations included inadequate protection of Source Plasma containers, failure to investigate seal failures, and a lack of concurrent documentation for critical processing steps. These issues indicate potential risks to product integrity and traceability.