FDA Inspection
Prothya Biosolutions Netherlands B.V.Prothya Biosolutions Netherlands B.V. – FDA Inspection, Mar 30, 2018
Record Details
This FDA Inspection record concerns Prothya Biosolutions Netherlands B.V., with an inspection on March 30, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 6a833c0f-cc25-48db-8a06-a2cc09695495
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046705
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
Other FDA inspections of Prothya Biosolutions Netherlands B.V.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 13, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 20, 2014 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 4, 2013 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 28, 2011 | OAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 15, 2009 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Prothya Biosolutions Netherlands B.V.
- FDA Inspection 969120 - 2016-05-13
- FDA Inspection 906173 - 2014-11-20
- FDA Inspection 835110 - 2013-06-04
- FDA Inspection 748170 - 2011-09-28
- FDA Inspection 620661 - 2009-09-15
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