FDA Inspection 1275471 — Hubei Qianjiang Kingphar Medical Material Co. Ltd.
The FDA completed an inspection of Hubei Qianjiang Kingphar Medical Material Co. Ltd. on July 3, 2025 in Qian Jiang. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 3, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: 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 |