FDA Inspection
Octapharma Plasma IncOctapharma Plasma Inc – FDA Inspection, Oct 20, 2017
Record Details
This FDA Inspection record concerns Octapharma Plasma Inc, with an inspection on October 20, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 40ebaaab-ea92-4f45-bd13-9e9804ecfdc5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1029299
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Octapharma Plasma Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| July 18, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 14, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 12, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 3, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 23, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Plasma Inc
- FDA Inspection 1277356 - 2025-07-18
- FDA Inspection 1072791 - 2018-11-14
- FDA Inspection 791773 - 2012-07-12
- FDA Inspection 738369 - 2011-08-03
- FDA Inspection 681948 - 2010-09-23
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