FDA 483 - Octapharma Plasma Inc - March 04, 2022

Octapharma Plasma Inc, a source plasma establishment in Knoxville, TN, was inspected by the FDA from February 23 to March 4, 2022. The inspection revealed significant deficiencies in the firm's adherence to its own written procedures for managing major deviations and corrective and preventive actions (CAPAs). Specifically, the firm failed to initiate CAPAs for several major deviations and did not close a substantial number of CAPAs within the required timeframe, indicating a systemic issue with quality system compliance.