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

Source: https://www.keypedia.com/records/483/biogen-international-gmbh/3fac2131-fbe0-485d-a9f7-3cf7c4fecddf

> 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 Pharmaceutical Manufacturing Assessment
- Summary: During an inspection conducted from October 6-9, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Biogen in Luterbach, Solothurn, Switzerland, a drug substance manufacturer. The observations highlighted significant deficiencies in adherence to current Good Manufacturing Practices (cGMP).

Key issues included a lack of process control assurance for drug substance manufacturing, evidenced by multiple failed process performance qualification batches, out-of-specification results, and over 570 deviations related to process parameter excursions. The company also failed to thoroughly evaluate these deviations, leading to ineffective corrective actions and an inability to assess potential microbial contamination risks following facility incidents.

Furthermore, the inspection identified an inadequate cleaning and sanitization program, with issues in disinfectant efficacy studies and continued recovery of spore-forming microorganisms in environmental monitoring. Facility and equipment maintenance was found lacking, with chipped paint, rust, and dirty equipment. Gowning procedures were also deemed inadequate, allowing the transfer of potential contaminants between different classified areas via footwear.

These observations indicate a need for comprehensive corrective and preventive actions to ensure product quality and compliance with regulatory standards. Biogen is expected to provide a detailed response addressing each observation.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/biogen-international-gmbh/225afcc6-eec3-4a2a-a270-8355edd2f9d0)
- [483 - 2025-10-09](https://www.keypedia.com/records/483/biogen-international-gmbh/c41c2586-1c18-4593-b79b-2736eb3f3003)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-manufacturing-assessment/fe47b0bd-c1c6-4458-a8c9-15e4b073d3df