FDA Inspection 735631 — Shanghai Kindly Enterprise Development Group Co., Ltd
The FDA completed an inspection of Shanghai Kindly Enterprise Development Group Co., Ltd on July 19, 2011 in Jiading. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 19, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Jiading (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3676 | 21 CFR 820.30(f) | Design verification - documentation |