FDA Inspection
Biogen, Inc.Biogen, Inc. – FDA Inspection, Jun 26, 2015
Record Details
This FDA Inspection record concerns Biogen, Inc., with an inspection on June 26, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Biogen, Inc.
- Inspection Date
- June 26, 2015
- Product Type
- Drugs
View Company Profile
ID · cb232309-58c1-4680-81ac-0ab520ce15d6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 932428
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.113(a)Procedures for non-sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biogen, Inc.
13| Date | Classification | Office | Project area |
|---|---|---|---|
| September 21, 2026 | Not classified | New England District Office | |
| November 4, 2022 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 2, 2022 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 10, 2020 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| September 1, 2020 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Biogen, Inc.
- FDA Inspection 1340116 - 2026-09-21
- FDA Inspection 1190494 - 2022-11-04
- FDA Inspection 1180550 - 2022-09-02
- FDA Inspection 1133055 - 2020-11-10
- FDA Inspection 1130379 - 2020-09-01
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.