FDA Inspection
Beijing Toplaser Technology Co., Ltd.Beijing Toplaser Technology Co., Ltd. – FDA Inspection, Apr 2, 2015
Record Details
This FDA Inspection record concerns Beijing Toplaser Technology Co., Ltd., with an inspection on April 2, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 2, 2015
- Product Type
- Devices
View Company Profile
ID · c090d556-e9b6-4424-b074-ba9fcece50c9
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 926274
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(c)Design input - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - 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 820.184DHR content
- 21 CFR 820.30(g)Design validation - documentation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
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Other FDA inspections of Beijing Toplaser Technology Co., Ltd.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 1, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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