FDA Inspection
CG MedTech Co., Ltd.CG MedTech Co., Ltd. – FDA Inspection, Jun 15, 2023
Record Details
This FDA Inspection record concerns CG MedTech Co., Ltd., with an inspection on June 15, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 94705ef1-9b69-48cf-b6ba-582bf9c9fd0d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1209400
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
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Other FDA inspections of CG MedTech Co., Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2026 | Not classified | Office of Inspections and Investigations | Postmarket Assurance: Devices |
| November 14, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 30, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 5, 2015 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for CG MedTech Co., Ltd.
- FDA Inspection 1327740 - 2026-09-10
- FDA Inspection 1112977 - 2019-11-14
- FDA Inspection 1023511 - 2017-03-30
- FDA Inspection 922594 - 2015-02-05
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