926501
Jiangsu Guangda Medical Material Group Co., Ltd. — FEI 3006847952
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 10, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Nantong (China)
Citations
| ID | CFR | Description |
|---|
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |