FDA Inspection 1019784 — Beijing Syntech Laser Co., Ltd
The FDA completed an inspection of Beijing Syntech Laser Co., Ltd on July 7, 2017 in Beijing. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 7, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Beijing (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5032 | 21 CFR 1010.2(b) | Certification label or tag |