# FDA 483 - Biogen International GmbH - October 09, 2025

Source: https://www.globalkeysolutions.net/records/483/biogen-international-gmbh/c41c2586-1c18-4593-b79b-2736eb3f3003

> FDA 483 for Biogen International GmbH on October 09, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biogen International GmbH
- Inspection Date: 2025-10-09
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/biogen-international-gmbh/225afcc6-eec3-4a2a-a270-8355edd2f9d0)
- [483 - 2025-10-09](https://www.globalkeysolutions.net/records/483/biogen-international-gmbh/3fac2131-fbe0-485d-a9f7-3cf7c4fecddf)

## Related Officers

- [Talia A. Faison](https://www.globalkeysolutions.net/people/talia-a-faison/87f5a1f7-db9b-48fd-adfc-3cbe24dba18f)
- [Biologist](https://www.globalkeysolutions.net/people/milos-dokmanovic/b6c79c1d-754a-46ab-977b-adc90cedcac2)
- [ Investigator, Consumer Safety Officer](https://www.globalkeysolutions.net/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)
- [Pharmaceutical Scientist](https://www.globalkeysolutions.net/people/mia-j-chang/3d26c94d-9fd5-4b5a-9cfb-72323d3db969)

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

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8