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854504

GE Healthcare Shanghai Co., Ltd. — FEI 3005292384

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 8, 2013
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Shanghai (China)

Facility

Other inspections at this facility

  • 1295560 (VAI Thu Oct 30 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1055016 (VAI Thu May 10 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 984196 (VAI Fri Aug 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 727732 (NAI Fri Apr 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 547503 (VAI Fri Oct 17 2008 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls