483
Biogen International GmbHBiogen International GmbH – FDA 483
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
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ID · 225afcc6-eec3-4a2a-a270-8355edd2f9d0
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