FDA Inspection
CG Bio Co., Ltd.CG Bio Co., Ltd. – FDA Inspection, Sep 11, 2025
Record Details
This FDA Inspection record concerns CG Bio Co., Ltd., with an inspection on September 11, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · ada61b80-f22c-4761-a653-b462c6617db2
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1281106
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
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 Bio Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 3, 2026 | Not classified | Office of Inspections and Investigations |
Other documents for CG Bio Co., Ltd.
- FDA Inspection 1341700 - 2026-09-03
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