Octapharma AB – FDA 483, Sep 19, 2023

Octapharma AB, a plasma derivatives manufacturer in Stockholm, Sweden, was cited for significant deficiencies during an FDA inspection. The firm failed to adequately record and justify deviations from production and process control procedures, including a lack of documented training for updated instructions and corrective actions. Additionally, equipment was not maintained at appropriate intervals, and written procedures for in-process controls and handling of failed materials were not established or followed.