FDA Inspection
Biogen U.S. CorporationBiogen U.S. Corporation – FDA Inspection, Dec 10, 2015
Record Details
This FDA Inspection record concerns Biogen U.S. Corporation, with an inspection on December 10, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Biogen U.S. Corporation
- Inspection Date
- December 10, 2015
- Product Type
- Drugs
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ID · a4fdbe55-da8d-4738-9432-7b6e0b4b439c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 951256
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.42(c)(10)(iii)Air Supply
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.142Written warehousing procedures established/followed
- 21 CFR 211.150Written distribution procedure
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biogen U.S. Corporation
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 17, 2023 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 26, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 4, 2018 | Not classified | Atlanta District Office | |
| April 16, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Biogen U.S. Corporation
- FDA Inspection 1220500 - 2023-10-17
- FDA Inspection 1178753 - 2022-08-26
- FDA Inspection 1052799 - 2018-05-04
- FDA Inspection 922850 - 2015-04-16
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