FDA Inspection 776430 — Jiangsu Yuyue Medical Equipment & Supply Co. Ltd.
The FDA completed an inspection of Jiangsu Yuyue Medical Equipment & Supply Co. Ltd. on Mar 22, 2012 in Danyang City. 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 22, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Danyang City (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |