FDA 483 - Sanofi-Aventis Deutschland GmbH - January 16, 2025

This FDA Form 483 was issued to Sanofi-Aventis Deutschland GmbH in Frankfurt am Main following an inspection of their drug substance and drug product facility. The observations primarily highlight significant deficiencies in aseptic processing, environmental control, and cleaning validation, indicating a lack of assurance in product sterility and quality. The findings suggest a need for comprehensive improvements in contamination prevention and manufacturing area control.