FDA Inspection
Octapharma Plasma, Inc. PortsmouthOctapharma Plasma, Inc. Portsmouth – FDA Inspection, Oct 28, 2016
Record Details
This FDA Inspection record concerns Octapharma Plasma, Inc. Portsmouth, with an inspection on October 28, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 15f7155b-22f1-4b9c-892d-3aa42f2ea425
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 992370
- 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
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Other FDA inspections of Octapharma Plasma, Inc. Portsmouth
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 30, 2021 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 26, 2018 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 20, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 28, 2011 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Plasma, Inc. Portsmouth
- FDA Inspection 1137609 - 2021-03-30
- FDA Inspection 1066750 - 2018-09-26
- FDA Inspection 838033 - 2013-06-20
- FDA Inspection 733852 - 2011-06-28
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