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1236691

GE Healthcare AS — FEI 3002807779

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 23, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Oslo (Norway)

Facility

Other inspections at this facility

  • 1100537 (VAI Tue Aug 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1037481 (VAI Fri Nov 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 959608 (NAI Fri Feb 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 915526 (NAI Tue Feb 03 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 810910 (VAI Thu Dec 13 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
121521 CFR 211.67(b)Written procedures not established/followed
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143621 CFR 211.42(c)(10)(vi)Equipment to control conditions
145121 CFR 211.113(b)Procedures for sterile drug products