# FDA 483 - BIOGEN, INC - November 02, 2026

Source: https://www.keypedia.com/records/483/biogen-inc/cd9c8967-b697-4f33-b4a0-ffbad68af2bc

> FDA 483 for BIOGEN, INC on November 02, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BIOGEN, INC
- Inspection Date: 2026-11-02
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of BIOGEN, INC in Cambridge, MA, identified two significant observations. The firm failed to adequately monitor the progress of an investigation under an IND, specifically regarding the trustworthiness and reliability of electronic records and audit trails. Additionally, the inspection found that the sponsor did not obtain sufficient financial information from clinical investigators, impacting the completeness and accuracy of required disclosure statements.

## Related Officers

- [BYRONDA E. MARCIANTE](https://www.keypedia.com/people/byronda-e-marciante/e99c1390-0028-43c2-b504-4f9933ee96f6)

Company: https://www.keypedia.com/companies/biogen-inc/9aa464ea-10e5-49ae-9b48-c7d8e92d15ca

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94