FDA Inspection
Octapharma Plasma, Inc.Octapharma Plasma, Inc. – FDA Inspection, Apr 8, 2016
Record Details
This FDA Inspection record concerns Octapharma Plasma, Inc., with an inspection on April 8, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Octapharma Plasma, Inc.
- Inspection Date
- April 8, 2016
- Product Type
- Biologics
View Company Profile
ID · 23222fd5-0c56-49db-bc7b-9d0554b082a5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 970304
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Octapharma Plasma, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 14, 2020 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 19, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 4, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 5, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Plasma, Inc.
- FDA Inspection 1132304 - 2020-10-14
- FDA Inspection 1069326 - 2018-09-19
- FDA Inspection 865923 - 2014-02-04
- FDA Inspection 779864 - 2012-04-05
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