FDA 483 - Biogen International GmbH - October 09, 2025

Biogen International GmbH, a drug substance manufacturer in Luterbach, Solothurn, Switzerland, was cited for significant deficiencies in its manufacturing process control, deviation management, cleaning and sanitization, facility maintenance, and gowning procedures. The inspection revealed a lack of process consistency, inadequate evaluation of deviations, and persistent microbial contamination risks. These issues indicate a serious lack of control over critical aspects of drug substance manufacturing.