FDA 483 - Biogen International GmbH - October 09, 2025
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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.
ID · c41c2586-1c18-4593-b79b-2736eb3f3003