FDA Inspection
Octapharma Plasma, Inc.Octapharma Plasma, Inc. – FDA Inspection, Dec 29, 2017
Record Details
This FDA Inspection record concerns Octapharma Plasma, Inc., with an inspection on December 29, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 6b0697a4-0c87-4f89-a0b9-84d51ae64f8c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1036565
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 640.73Reporting of fatal donor reactions
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Other FDA inspections of Octapharma Plasma, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 16, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 6, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 23, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 10, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Octapharma Plasma, Inc.
- FDA Inspection 1172652 - 2022-06-16
- FDA Inspection 865572 - 2014-02-06
- FDA Inspection 760574 - 2011-12-23
- FDA Inspection 597584 - 2009-07-10
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