FDA Inspection 756492 — Beijing Toplaser Technology Co., Ltd.
The FDA completed an inspection of Beijing Toplaser Technology Co., Ltd. on December 1, 2011 in Beijing. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 1, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Beijing (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5032 | 21 CFR 1010.2(b) | Certification label or tag |
| 5042 | 21 CFR 1010.3(a) | ID label or tag |
| 5171 | 21 CFR 1040.10(g)(3) | Class IV "Danger" label |