FDA Inspection
Techtronic Industries (Dongguan) Co. Ltd.Techtronic Industries (Dongguan) Co. Ltd. – FDA Inspection, Dec 9, 2010
Record Details
This FDA Inspection record concerns Techtronic Industries (Dongguan) Co. Ltd., with an inspection on December 9, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 9, 2010
- Product Type
- Devices
View Company Profile
ID · ff85ff37-0635-4585-9e56-7fc729935702
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 705026
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
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Other FDA inspections of Techtronic Industries (Dongguan) Co. Ltd.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 12, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 8, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Techtronic Industries (Dongguan) Co. Ltd.
- FDA Inspection 917035 - 2015-02-12
- FDA Inspection 705723 - 2010-12-08
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