Company
ChinaCotronic Technology Limited, Shenzhen, China – FDA Inspections
Inspection records and compliance data for Cotronic Technology Limited in Shenzhen. 3 FDA inspections on record (1 OAI), 1 warning letter, last inspected July 28, 2016.
Company Profile
This profile covers Cotronic Technology Limited based in Shenzhen, China.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 1
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 1
First inspected June 14, 2012. Last inspected July 28, 2016.
Most cited issue areas
- Design verification - output does not meet input requirement1 inspection
- DHR - not or inadequately maintained1 inspection
- Documentation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 28, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 988227 |
| July 16, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 937050 |
| June 14, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 791021 |
FDA documents
Warning Letters (1)
People (1)
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Company Information
Name
Cotronic Technology Limited
FEI Number
3004215929
Address
Floors 4-6, Block 7, West Of Zhoushi Road; Baoan, Shenzhen, China
Country
China
ID: fd100e2d-811f-4824-8965-8226b50445d1