Company
ChinaGMDASZ Manufacturing Co., Ltd., Shenzhen, China – FDA Inspections
Inspection records and compliance data for GMDASZ Manufacturing Co., Ltd. in Shenzhen. 3 FDA inspections on record, 2 Form 483s, last inspected August 15, 2019.
Company Profile
This profile covers GMDASZ Manufacturing Co., Ltd. based in Shenzhen, China.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected January 29, 2015. Last inspected August 15, 2019.
Most cited issue areas
- Design validation - production units1 inspection
- Documentation1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 15, 2019 | Not classified | Medical Devices & Rad Health | 1121461 |
| January 18, 2018 | Not classified | Medical Devices & Rad Health | 1039827 |
| January 29, 2015 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 913245 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
GMDASZ Manufacturing Co., Ltd.
FEI Number
3008197884
Address
Xixiang B1, Baoan, Shenzhen, China
Country
China
ID: 75d937ba-3c69-457e-bbe6-d1c04ee4c9ae