Biogen International GmbH

FDA 483 - Biogen International GmbH

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Record Details

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.

Company: Biogen International GmbH
Product Type: Drugs
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Leiyun W. Boone (Lead Biologist)
Richard Ledwidge

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ID · 225afcc6-eec3-4a2a-a270-8355edd2f9d0