Company
ChinaShanghai Amsino Medical Devices Co., Ltd., Shanghai, China – FDA Inspections
Inspection records and compliance data for Shanghai Amsino Medical Devices Co., Ltd. in Shanghai. 1 FDA inspection on record, last inspected March 29, 2012.
Company Profile
This profile covers Shanghai Amsino Medical Devices Co., Ltd. based in Shanghai, China.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected March 29, 2012.
Most cited issue areas
- Design validation - documentation1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Design verification - documentation1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 29, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 781857 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Other regulators (1)
- China NMPA · 1 inspection · last October 30, 2018
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Company Information
Name
Shanghai Amsino Medical Devices Co., Ltd.
FEI Number
3003238685
Address
No 5 Huajiang Road, Shanghai, China
Country
China
ID: c2b7f98f-5bac-4401-8f3b-e278676070d4