FDA 483 - Merck Serono SA - July 08, 2022

Merck Serono S.A. (MS-Aubonne) in Aubonne, Switzerland, was inspected by the FDA, revealing significant deficiencies in its sterile drug product manufacturing processes. The inspection highlighted inadequate procedures for preventing microbiological contamination, environmental monitoring, cleaning and disinfection, and critical utility qualification. Additionally, the firm's deviation investigations, electronic data system controls, and quality assurance oversight were found to be insufficient, indicating a broad range of issues impacting product sterility and quality.