FDA 483 - Octapharma Produktionsgesellschaft Deutschland mbH - June 11, 2024

Octapharma Produktionsgesellschaft Deutschland mbH in Springe, Germany, was cited for significant deficiencies across its manufacturing operations, primarily concerning inadequate computer system validation and control, and a weak quality system. The inspection revealed issues with automated system qualification, unauthorized batch release, insufficient deviation investigations, untimely CAPA closures, and neglected equipment maintenance. These findings indicate a systemic lack of control over critical manufacturing processes and quality assurance.