FDA Inspection
Everlife Medical Equipment Co., Ltd.Everlife Medical Equipment Co., Ltd. – FDA Inspection, Mar 12, 2015
Record Details
This FDA Inspection record concerns Everlife Medical Equipment Co., Ltd., with an inspection on March 12, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 12, 2015
- Product Type
- Devices
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ID · 4a0c126f-3ace-4a84-a461-ac3b190be3e3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 920497
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Everlife Medical Equipment Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 14, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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