FDA Inspection
Jiangsu Yuyue Medical Equipment & Supply Co. Ltd.Jiangsu Yuyue Medical Equipment & Supply Co. Ltd. – FDA Inspection, Mar 22, 2012
Record Details
This FDA Inspection record concerns Jiangsu Yuyue Medical Equipment & Supply Co. Ltd., with an inspection on March 22, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 22, 2012
- Product Type
- Devices
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ID · c50abb05-d69f-4921-a6ee-78bc3789eccf
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 776430
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.184DHR content
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Jiangsu Yuyue Medical Equipment & Supply Co. Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 11, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Jiangsu Yuyue Medical Equipment & Supply Co. Ltd.
- FDA Inspection 907971 - 2014-12-11
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