FDA Inspection
GEV Co LtdGEV Co Ltd – FDA Inspection, Sep 6, 2023
Record Details
This FDA Inspection record concerns GEV Co Ltd, with an inspection on September 6, 2023, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 0ad29a84-2ef6-4b2c-b97d-2405786c3dc2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1218362
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
Other FDA inspections of GEV Co Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| April 16, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| May 27, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for GEV Co Ltd
- FDA Inspection 1294010 - 2025-09-17
- FDA Inspection 1089913 - 2019-04-16
- FDA Inspection 890859 - 2014-05-27
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