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FDA Inspection 965894 — Swedish Orphan Biovitrum AB (Publ)

Swedish Orphan Biovitrum AB (Publ) — FEI 3003455777

The FDA completed an inspection of Swedish Orphan Biovitrum AB (Publ) on March 22, 2016 in Stockholm. 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 22, 2016
Fiscal Year
2016
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Stockholm (Sweden)

Facility

Other inspections at this facility

  • 1105180 (NAI Thu Aug 29 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1050664 (VAI Fri May 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 886772 (VAI Thu May 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 822730 (NAI Fri Feb 22 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 725457 (VAI Thu Jan 27 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources