FDA Inspection
Cotronic Technology LimitedCotronic Technology Limited – FDA Inspection, Jun 14, 2012
Record Details
This FDA Inspection record concerns Cotronic Technology Limited, with an inspection on June 14, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cotronic Technology Limited
- Inspection Date
- June 14, 2012
- Product Type
- Devices
View Company Profile
ID · 1458a1fe-b275-48db-976a-13bb6323b92d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 791021
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of Cotronic Technology Limited
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 28, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 16, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cotronic Technology Limited
- FDA Inspection 988227 - 2016-07-28
- FDA Inspection 937050 - 2015-07-16
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