FDA 483 - Octapharma S.A.S.

An FDA inspection of Octapharma S.A.S. in Lingolsheim, France, a blood product manufacturer, revealed significant deficiencies in their quality system. The firm was cited for inadequate investigations into unexplained discrepancies, untimely implementation of corrective and preventive actions (CAPAs), and incomplete process validation. Additionally, deficient procedures and a lack of change control for recurring human error deviations were observed, indicating a need for improved manufacturing controls.