FDA Inspection
GE Healthcare Shanghai Co., Ltd.GE Healthcare Shanghai Co., Ltd. – FDA Inspection, May 10, 2018
Record Details
This FDA Inspection record concerns GE Healthcare Shanghai Co., Ltd., with an inspection on May 10, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Eric L. Dong (Issuing Officer)
- Lane V. Christensen (Issuing Officer)
View Company Profile
ID · 1811daac-5c87-4b2a-a09a-6c1c3e820ba8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1055016
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
Other FDA inspections of GE Healthcare Shanghai Co., Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 30, 2025 | Not classified | Office of Inspections and Investigations | |
| August 12, 2016 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| November 8, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 15, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 17, 2008 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for GE Healthcare Shanghai Co., Ltd.
- FDA Inspection 1295560 - 2025-10-30
- 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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