# FDA 483 - Biogen International GmbH - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/biogen-international-gmbh/225afcc6-eec3-4a2a-a270-8355edd2f9d0

> FDA 483 for Biogen International GmbH on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biogen International GmbH
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

## Related Documents

- [483 - 2025-10-09](https://www.globalkeysolutions.net/records/483/biogen-international-gmbh/3fac2131-fbe0-485d-a9f7-3cf7c4fecddf)
- [483 - 2025-10-09](https://www.globalkeysolutions.net/records/483/biogen-international-gmbh/c41c2586-1c18-4593-b79b-2736eb3f3003)

## Related Officers

- [Lead  Biologist](https://www.globalkeysolutions.net/people/leiyun-w-boone/454ce531-ae82-4ae4-9b3d-8e4e8afed127)
- [Richard Ledwidge](https://www.globalkeysolutions.net/people/richard-ledwidge/aaf4f089-8f7a-4d1f-b2e1-5f2e476a22a9)

Company: https://www.globalkeysolutions.net/companies/biogen-international-gmbh/204a24e4-d346-4dc4-b78a-ed40c3085d13

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd