FDA Inspection
Wujiang Jia Chen Acupuncture Devices Co., Ltd.Wujiang Jia Chen Acupuncture Devices Co., Ltd. – FDA Inspection, Oct 29, 2015
Record Details
This FDA Inspection record concerns Wujiang Jia Chen Acupuncture Devices Co., Ltd., with an inspection on October 29, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 29, 2015
- Product Type
- Devices
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ID · c1261bf0-1a7a-4f24-9ad6-529ccb4b472b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 948672
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.184DHR content
- 21 CFR 803.17Lack of Written MDR Procedures
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