FDA Inspection 854360 — Zhongshan Transtek Electronics Co., Ltd.
The FDA completed an inspection of Zhongshan Transtek Electronics Co., Ltd. on October 17, 2013 in Zhongshan. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 17, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Zhongshan (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3677 | 21 CFR 820.30(g) | Design validation - software validation not performed |