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FDA Inspection
•Prothya Biosolutions Netherlands B.V.•November 20, 2014

Prothya Biosolutions Netherlands B.V. – FDA Inspection, Nov 20, 2014

Record Details

This FDA Inspection record concerns Prothya Biosolutions Netherlands B.V., with an inspection on November 20, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Prothya Biosolutions Netherlands B.V.
Inspection Date
November 20, 2014
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 3b7af2f8-afcc-4f9f-bc35-22aa3a72c00a

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
906173
FDA center
Biologics
Project area
Blood and Blood Products

Other FDA inspections of Prothya Biosolutions Netherlands B.V.

5
DateClassificationOfficeProject area
March 30, 2018VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
May 13, 2016VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 4, 2013OAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 28, 2011OAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 15, 2009VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Prothya Biosolutions Netherlands B.V.
  • FDA Inspection 1046705 - 2018-03-30
  • FDA Inspection 969120 - 2016-05-13
  • FDA Inspection 835110 - 2013-06-04
  • FDA Inspection 748170 - 2011-09-28
  • FDA Inspection 620661 - 2009-09-15

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