FDA Inspection
Octapharma Plasma, Inc.Octapharma Plasma, Inc. – FDA Inspection, Jul 24, 2012
Record Details
This FDA Inspection record concerns Octapharma Plasma, Inc., with an inspection on July 24, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Octapharma Plasma, Inc.
- Inspection Date
- July 24, 2012
- Product Type
- Biologics
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ID · 3a8cad01-cc76-4323-93db-4e04b2a26a1f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 793025
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 640.120Alternative procedures
- 21 CFR 640.64(e)Prevention of contamination
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Other FDA inspections of Octapharma Plasma, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 1, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 29, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 10, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 24, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Plasma, Inc.
- FDA Inspection 1259244 - 2024-12-13
- FDA Inspection 1047796 - 2018-03-01
- FDA Inspection 986379 - 2016-09-29
- FDA Inspection 913736 - 2015-02-10
- FDA Inspection 897378 - 2014-09-24
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