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657027

GE Healthcare Inc. — FEI 1417338

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 8, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Arlington Heights, IL (United States)

Facility

Other inspections at this facility

  • 1287530 (NAI Fri Sep 19 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1232232 (VAI Fri Mar 08 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1117219 (NAI Fri Jan 24 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1026911 (NAI Wed Sep 06 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 916324 (NAI Thu Mar 05 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
202721 CFR 211.192Investigations of discrepancies, failures
203121 CFR 211.194(a)Complete test data included in records
358521 CFR 211.110(a)Control procedures to monitor and validate performance