# FDA 483 - Biogen U.S. Corporation - October 17, 2023

Source: https://www.globalkeysolutions.net/records/483/biogen-us-corporation/8886ac1d-105c-4d15-91d3-69f07c9d673e

> FDA 483 for Biogen U.S. Corporation on October 17, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Biogen U.S. Corporation
- Inspection Date: 2023-10-17
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Biogen U.S. Corporation in Durham, NC, was cited for significant deficiencies during an FDA inspection, primarily concerning quality control and manufacturing processes for sterile drug products. The firm failed to thoroughly investigate unexplained discrepancies, particularly regarding toxin-producing microorganisms and environmental contamination. Additional issues included inadequate microbiological contamination prevention procedures, insufficient laboratory controls for microbial testing, lack of process validation for critical equipment, and unestablished procedures for handling product complaints, including chipped vials.

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## Related Officers

- [Consumer Safety Officer at Commissioned Corps of the U.S. Public Health Service](https://www.globalkeysolutions.net/people/latorie-s-jones/086d0897-7d63-4fa8-bdce-f1d17885abd7)
- [Gene D. Arcy](https://www.globalkeysolutions.net/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)

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

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