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FDA Inspection
•GE Healthcare Shanghai Co., Ltd.•August 12, 2016

GE Healthcare Shanghai Co., Ltd. – FDA Inspection, Aug 12, 2016

Record Details

This FDA Inspection record concerns GE Healthcare Shanghai Co., Ltd., with an inspection on August 12, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
GE Healthcare Shanghai Co., Ltd.
Inspection Date
August 12, 2016
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 063422a6-f456-4ea8-81a2-4e92c966b37a

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
984196
FDA center
Human Drugs
Project area
Drug Quality Assurance

Other FDA inspections of GE Healthcare Shanghai Co., Ltd.

5
DateClassificationOfficeProject area
October 30, 2025Not classifiedOffice of Inspections and Investigations
May 10, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
November 8, 2013VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 15, 2011NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 17, 2008VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for GE Healthcare Shanghai Co., Ltd.
  • FDA Inspection 1295560 - 2025-10-30
  • FDA Inspection 1055016 - 2018-05-10
  • FDA Inspection 854504 - 2013-11-08
  • FDA Inspection 727732 - 2011-04-15
  • FDA Inspection 547503 - 2008-10-17

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