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FDA Inspection 1046705 — Prothya Biosolutions Netherlands B.V.

Prothya Biosolutions Netherlands B.V. — FEI 3007166802

The FDA completed an inspection of Prothya Biosolutions Netherlands B.V. on March 30, 2018 in Amsterdam. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 30, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Amsterdam (Netherlands)

Facility

Other inspections at this facility

  • 969120 (VAI Fri May 13 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 906173 (OAI Thu Nov 20 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 835110 (OAI Tue Jun 04 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 748170 (OAI Wed Sep 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 620661 (VAI Tue Sep 15 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources