Hubei Qianjiang Kingphar Medical Material Co., Ltd
YUANGUANG ROAD., QIANJIANG, HUBEI, CN
Registered product codes
52 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3002897187.
FDA inspections
2 on file
- Official Action Indicated (OAI)Jul 3, 2025
Compliance: Devices · Citations posted
- Official Action Indicated (OAI)Jul 3, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗21 CFR 803.17(a)(2)Lack of System for Determining MDR Events
121 CFR 820.20(c)Management review - Lack of or inadequate procedures
121 CFR 820.22Quality Audit/Reaudit - documentation
121 CFR 820.70(c)Environmental control Lack of or inadequate procedures
121 CFR 820.75(a)Documentation
121 CFR 820.100(b)Documentation
1
- 21 CFR 803.17(a)(2)Jul 3, 2025
Lack of System for Determining MDR Events
- 21 CFR 820.20(c)Jul 3, 2025
Management review - Lack of or inadequate procedures
- 21 CFR 820.22Jul 3, 2025
Quality Audit/Reaudit - documentation
- 21 CFR 820.70(c)Jul 3, 2025
Environmental control Lack of or inadequate procedures
- 21 CFR 820.75(a)Jul 3, 2025
Documentation
- 21 CFR 820.100(b)Jul 3, 2025
Documentation
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.