# FDA 483 - Biogen U.S. Corporation - August 19, 2022

Source: https://www.keypedia.com/records/483/biogen-us-corporation/4b8c485a-80e3-4311-999d-a8448d1caed5

> FDA 483 for Biogen U.S. Corporation on August 19, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Biogen U.S. Corporation
- Inspection Date: 2022-08-19
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Biogen U.S. Corporation in Research Triangle Park, NC, underwent an FDA inspection of its drug manufacturing facility. The inspection identified a critical lapse in data integrity and control, specifically the absence of procedures to review calculations within an un-validated Excel spreadsheet. This spreadsheet was used for establishing Assay Acceptance Criteria for Tofersen drug substance and drug product, indicating a failure to ensure accuracy in related data systems.

## Related Documents

- [483 - 2022-08-26](https://www.keypedia.com/records/483/biogen-us-corporation/667d7216-c2bd-4cea-a142-5c67b32a6b12)
- [483 - 2022-12-09](https://www.keypedia.com/records/483/biogen-us-corporation/726781bf-1eb0-471e-85bb-fc1952ea7a7d)
- [483 - 2023-10-17](https://www.keypedia.com/records/483/biogen-us-corporation/8886ac1d-105c-4d15-91d3-69f07c9d673e)

## Related Officers

- [Pharmaceutical Specialist/ Investigator ](https://www.keypedia.com/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)
- [Strategic Communications Specialist, Consumer Safety Officer](https://www.keypedia.com/people/lavalais-song/ea936f12-0c09-43db-895c-24bb2efa5a90)

Company: https://www.keypedia.com/companies/biogen-us-corporation/515ce53c-77be-414c-bcf4-c66be60b098e

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7