Company
United StatesBiogen U.S. Corporation, Durham, NC – FDA Inspections
Inspection records and compliance data for Biogen U.S. Corporation in Durham, North Carolina. 5 FDA inspections on record, 2 Form 483s, last inspected October 17, 2023.
Company Profile
This profile covers Biogen U.S. Corporation based in Durham, North Carolina, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected April 16, 2015. Last inspected October 17, 2023.
Most cited issue areas
- Air Supply1 inspection
- Cleaning / Sanitizing / Maintenance1 inspection
- Control procedures to monitor and validate performance1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 17, 2023 | VAI | Biologics · Blood and Blood Products | 1220500 |
| August 26, 2022 | VAI | Human Drugs · Drug Quality Assurance | 1178753 |
| May 4, 2018 | Not classified | Human Drugs | 1052799 |
| December 10, 2015 | VAI | Human Drugs · Drug Quality Assurance | 951256 |
| April 16, 2015 | NAI | Human Drugs · Drug Quality Assurance | 922850 |
FDA documents
People (5)
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Company Information
Name
Biogen U.S. Corporation
FEI Number
3010164829
Address
900 Davis Dr, Durham, North Carolina 27709, United States
Country
United States
ID: 515ce53c-77be-414c-bcf4-c66be60b098e