FDA Inspection
CG MedTech Co., Ltd.CG MedTech Co., Ltd. – FDA Inspection, Sep 10, 2026
Record Details
This FDA Inspection record concerns CG MedTech Co., Ltd., with an inspection on September 10, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- CG MedTech Co., Ltd.
- Inspection Date
- September 10, 2026
- Product Type
- Medical Devices & Rad Health
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ID · be37fc35-a946-44e0-8a7f-9ce7821f0138
Inspection Facts
- Inspection number
- 1327740
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 806.10(b)Time to report - 10 days
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
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Other FDA inspections of CG MedTech Co., Ltd.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2023 | VAI | Center for Devices and Radiological Health | 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 1209400 - 2023-06-15
- FDA Inspection 1112977 - 2019-11-14
- FDA Inspection 1023511 - 2017-03-30
- FDA Inspection 922594 - 2015-02-05
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