Company
ChinaGuangdong Transtek Medical Electronics Co., Ltd., Zhongshan, China – FDA Inspections
Inspection records and compliance data for Guangdong Transtek Medical Electronics Co., Ltd. in Zhongshan. 2 FDA inspections on record, 2 Form 483s, last inspected October 25, 2024.
Company Profile
This profile covers Guangdong Transtek Medical Electronics Co., Ltd. based in Zhongshan, China.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected April 6, 2017. Last inspected October 25, 2024.
Most cited issue areas
- Design validation - documentation1 inspection
- Design verification - documentation1 inspection
- Individual Report of Malfunction1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 25, 2024 | Not classified | Medical Devices & Rad Health | 1254459 |
| April 6, 2017 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1010444 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Guangdong Transtek Medical Electronics Co., Ltd.
FEI Number
3011420269
Address
Zone A, No. 105 Dongli Road, Torch Development District, Zhongshan, China
Country
China
ID: 6d80429b-1754-4585-aa4f-699e53e295d1