FDA Inspection
CG MedTech Co. LtdCG MedTech Co. Ltd – FDA Inspection, Sep 11, 2025
Record Details
This FDA Inspection record concerns CG MedTech Co. Ltd, with an inspection on September 11, 2025, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d617aa18-c263-4e86-89aa-63f29d1e9dd6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1281106
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
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Other FDA inspections of CG MedTech Co. Ltd
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 8, 2026 | Not classified | Office of Inspections and Investigations | |
| March 25, 2016 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 25, 2009 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for CG MedTech Co. Ltd
- FDA Inspection 1341056 - 2026-09-08
- FDA Inspection 966649 - 2016-03-25
- FDA Inspection 620307 - 2009-09-25
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