FDA Inspection 735631 — Shanghai Kindly Enterprise Development Group Co., Ltd
The FDA completed an inspection of Shanghai Kindly Enterprise Development Group Co., Ltd on Jul 19, 2011 in Jiading. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 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 |