Company
United StatesPublic company, NASDAQ: BIIBBiogen, Inc. (NASDAQ: BIIB), Cambridge, MA – FDA Inspections
Inspection records and compliance data for Biogen, Inc. in Cambridge, Massachusetts. 14 FDA inspections on record, 1 Form 483, last inspected September 21, 2026. Publicly traded as NASDAQ: BIIB.
Company Profile
This profile covers Biogen, Inc. based in Cambridge, Massachusetts, United States.
FDA Inspection History
- FDA inspections
- 14
- OAI
- 0
- VAI
- 8
- NAI
- 5
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 30, 2009. Last inspected September 21, 2026.
Most cited issue areas
- Late submission of 15-day report3 inspections
- Late submission of annual safety reports1 inspection
- Non-applicant reports directly to FDA1 inspection
FDA inspections (14)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 21, 2026 | Not classified | Human Drugs | 1340116 |
| November 4, 2022 | NAI | Human Drugs · Bioresearch Monitoring | 1190494 |
| September 2, 2022 | NAI | Human Drugs · Bioresearch Monitoring | 1180550 |
| November 10, 2020 | VAI | Human Drugs · Bioresearch Monitoring | 1133055 |
| September 1, 2020 | NAI | Human Drugs · Bioresearch Monitoring | 1130379 |
| February 13, 2018 | NAI | Biologics · Blood and Blood Products | 1046583 |
| April 6, 2017 | VAI | Human Drugs · Bioresearch Monitoring | 1008333 |
| February 9, 2016 | VAI | Biologics, Human Drugs · Drug Quality Assurance | 958791 |
| June 26, 2015 | VAI | Human Drugs · Drug Quality Assurance | 932428 |
| July 3, 2014 | VAI | Human Drugs · Bioresearch Monitoring | 886560 |
| March 15, 2013 | VAI | Human Drugs · Drug Quality Assurance | 822698 |
| June 27, 2012 | NAI | Human Drugs · Bioresearch Monitoring | 791734 |
| September 8, 2010 | VAI | Human Drugs · Drug Quality Assurance | 680914 |
| September 30, 2009 | VAI | Human Drugs · Bioresearch Monitoring | 621610 |
FDA documents
Form 483s (1)
Other FDA documents (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Biogen, Inc.
Stock ticker
BIIB
Exchange
NASDAQ
Share price
$250.48
Market cap
$37.0B
Price as of
November 13, 2026
FEI Number
1220951
Address
225 Binney St, Cambridge, Massachusetts 02142, United States
Country
United States
ID: 2cf09880-2ef1-4fb7-9690-fa729e4da5c4