FDA Inspection
Shanghai Amsino Medical Devices Co., Ltd.Shanghai Amsino Medical Devices Co., Ltd. – FDA Inspection, Mar 29, 2012
Record Details
This FDA Inspection record concerns Shanghai Amsino Medical Devices Co., Ltd., with an inspection on March 29, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 29, 2012
- Product Type
- Devices
View Company Profile
ID · 77342ec6-5112-4d35-a775-3a0556c57138
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 781857
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.30(g)Design validation - documentation
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