1275471
Hubei Qianjiang Kingphar Medical Material Co. Ltd. — FEI 3002897187
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 3, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Qian Jiang (China)
Citations
| ID | CFR | Description |
|---|
| 2339 | 21 CFR 820.22 | Quality Audit/Reaudit - documentation |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |