FDA Inspection 926274 — Beijing Toplaser Technology Co., Ltd.
The FDA completed an inspection of Beijing Toplaser Technology Co., Ltd. on April 2, 2015 in Beijing. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 2, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Beijing (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |