FDA Inspection
Biogen, Inc.Biogen, Inc. – FDA Inspection, Apr 6, 2017
Record Details
This FDA Inspection record concerns Biogen, Inc., with an inspection on April 6, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Erik W. Koester (FDA Associated Person)
- John P. Mistler (FDA Associated Person)
- Richard A. Abate (Issuing Officer)
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ID · b10dee32-12db-4414-acb5-6ae0e258197d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1008333
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
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
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