FDA Inspection 841544 — Beijing Syntech Laser Co., Ltd
The FDA completed an inspection of Beijing Syntech Laser Co., Ltd on July 12, 2013 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
- July 12, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Beijing (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3688 | 21 CFR 820.100(a)(1) | Analysis of data/reports from data sources |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5200 | 21 CFR 1040.10(h)(1)(iv) | User info - list controls, etc. |
| 5203 | 21 CFR 1040.10(h)(2)(i) | Reproduction of affixed information |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |