FDA Inspection
Gemore Technology Co., Ltd.Gemore Technology Co., Ltd. – FDA Inspection, Jul 21, 2016
Record Details
This FDA Inspection record concerns Gemore Technology Co., Ltd., with an inspection on July 21, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Gemore Technology Co., Ltd.
- Inspection Date
- July 21, 2016
- Product Type
- Devices
View Company Profile
ID · 45d90cd8-5e26-427a-809e-297d041004cd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 984865
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - simulated testing
- 21 CFR 820.30(g)Design validation - documentation
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Other FDA inspections of Gemore Technology Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 20, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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