# BIOGEN, INC – FDA 483, Oct 20, 2020

Source: https://www.keypedia.com/records/483/biogen-inc/df284e53-6e20-4e89-a0e7-8a32539cf7ce

> FDA 483 for BIOGEN, INC on October 20, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BIOGEN, INC
- Inspection Date: 2020-10-20
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of BIOGEN, INC in Cambridge, MA, revealed two significant observations. The firm failed to adequately monitor an IND investigation, specifically regarding the trustworthiness and reliability of electronic records and audit trails. Additionally, the inspection found that the sponsor did not obtain sufficient financial disclosure information from clinical investigators for multiple studies.

## 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/1414055b-f71c-447a-be86-72fcf2bc6d65

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