FDA Inspection
Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd. – FDA Inspection, Mar 12, 2015
Record Details
This FDA Inspection record concerns Suzhou Huanqiu Acupuncture Medical Appliance 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 · e1e4f48d-c6b2-450d-8be6-55460b58edbb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 921257
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(b)Documentation
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 1, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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