FDA 483 - Biogen International GmbH

Biogen International GmbH, a drug substance manufacturing facility in Luterbach, Switzerland, received a Form 483 with four observations. The inspection revealed deficiencies in vendor qualification for raw materials, inadequate documentation for reference standard traceability, and insufficient microbial control assurance for drug substance manufacturing processes. Additionally, microbial validation data supporting a specific storage tank operation was found to be inadequate.