FDA 483 - Octapharma Dessau GmbH - November 08, 2024

Octapharma Dessau GmbH received a Form 483 for deficiencies in their quality system, specifically regarding biological product deviation reporting, investigation records, batch production documentation, and quality control unit responsibilities. The inspection revealed issues with misaligned SOPs, lack of effectiveness checks for corrective actions, undocumented critical packaging steps, and inadequate qualification of visual inspection equipment. These findings indicate a need for improved procedural alignment and robust quality oversight to ensure product quality and compliance.