FDA Inspection
Techtronic Industries (Dongguan) Co. Ltd.Techtronic Industries (Dongguan) Co. Ltd. – FDA Inspection, Dec 8, 2010
Record Details
This FDA Inspection record concerns Techtronic Industries (Dongguan) Co. Ltd., with an inspection on December 8, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- December 8, 2010
- Product Type
- Devices
View Company Profile
ID · 048112c8-cac3-4dcf-8908-a156163b6ecf
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 705723
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
- 21 CFR 820.120Lack of or inadequate procedures for labeling
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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 9, 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 705026 - 2010-12-09
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