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1100537

GE Healthcare AS — FEI 3002807779

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 27, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Oslo (Norway)

Facility

Other inspections at this facility

  • 1236691 (VAI Tue Apr 23 2024 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
1781321 CFR 212.50(a)Written control procedures
193221 CFR 211.167(a)Sterility/pyrogen-free testing
202321 CFR 211.188(b)(11)Identification of Persons Performing Significant Steps
202721 CFR 211.192Investigations of discrepancies, failures