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FDA Inspection
•GE Healthcare Shanghai Co., Ltd.•October 30, 2025

GE Healthcare Shanghai Co., Ltd. – FDA Inspection, Oct 30, 2025

Record Details

This FDA Inspection record concerns GE Healthcare Shanghai Co., Ltd., with an inspection on October 30, 2025, issued by the Office of Inspections and Investigations, covering human drugs.

Company
GE Healthcare Shanghai Co., Ltd.
Inspection Date
October 30, 2025
Product Type
Human Drugs
Office
Office of Inspections and Investigations
Person
  • Dipesh K. Shah
View Company Profile

ID · fb2d871b-bf09-4fe8-adb2-e28b84816952

Inspection Facts

Inspection number
1295560
FDA center
Human Drugs
Outcome
Form 483 issued, view the record

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

5
DateClassificationOfficeProject area
May 10, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
August 12, 2016VAICenter 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 1055016 - 2018-05-10
  • FDA Inspection 984196 - 2016-08-12
  • FDA Inspection 854504 - 2013-11-08
  • FDA Inspection 727732 - 2011-04-15
  • FDA Inspection 547503 - 2008-10-17

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