FDA Inspection
GE Healthcare Shanghai Co., Ltd.GE Healthcare Shanghai Co., Ltd. – FDA Inspection, Nov 8, 2013
Record Details
This FDA Inspection record concerns GE Healthcare Shanghai Co., Ltd., with an inspection on November 8, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- November 8, 2013
- Product Type
- Drugs
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ID · 12c374ac-5541-4c8e-ad77-bc6a0457f598
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 854504
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
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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 | |
| May 10, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 12, 2016 | 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 1055016 - 2018-05-10
- FDA Inspection 984196 - 2016-08-12
- FDA Inspection 727732 - 2011-04-15
- FDA Inspection 547503 - 2008-10-17
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