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918929

Emergent BioSolutions Canada Inc. — FEI 3003153579

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 3, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Winnipeg (Canada)

Facility

Other inspections at this facility

  • 1109095 (VAI Fri Sep 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1018375 (VAI Tue May 16 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 905505 (VAI Fri Jul 18 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 798543 (VAI Thu Jun 21 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 772122 (VAI Wed Oct 19 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
143521 CFR 211.42(c)(10)(v)Cleaning System
145221 CFR 211.113(b)Validation lacking for sterile drug products