Nipro Renal Solutions Usa, Corporation
509 Fishing Creek Rd, LEWISBERRY, PA, US
Registered product codes
1 product codes
Recent MDR events
45 on file
- MEDICALYTEJun 3, 2025Malfunction1528807-2025-00033
- MEDICALYTEJun 3, 2025Malfunction1528807-2025-00034
- MEDICALYTEJun 3, 2025Malfunction1528807-2025-00036
- MEDICALYTEJun 3, 2025Malfunction1528807-2025-00037
- MEDICALYTEJun 3, 2025Malfunction1528807-2025-00035
- MEDICALYTEJun 3, 2025Malfunction1528807-2025-00038
- MEDICALYTEJun 3, 2025Injury1528807-2025-00039
- MEDICALYTEJun 3, 2025Malfunction1528807-2025-00040
- MEDICALYTEJun 2, 2025Malfunction1528807-2025-00015
- MEDICALYTEJun 2, 2025Malfunction1528807-2025-00014
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1000142899.
FDA inspections
1 on file
- Official Action Indicated (OAI)Mar 27, 2026
Compliance: Devices · Citations posted
Inspection citations
15 on file
Top cited requirements
Compare to industry ↗ISO 13485:2016 Clause 8.3.1Nonconforming product not identified and controlled
2ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
1ISO 13485:2016 Clause 4.2.3Medical device file not established and maintained
1ISO 13485:2016 Clause 6.3Maintenance records not maintained
1ISO 13485:2016 Clause 6.4.1Work environment requirements and procedures not documented
1ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented
1
- ISO 13485:2016 Clause 4.1.2Mar 27, 2026
Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 4.2.3Mar 27, 2026
Medical device file not established and maintained
- ISO 13485:2016 Clause 6.3Mar 27, 2026
Maintenance records not maintained
- ISO 13485:2016 Clause 6.4.1Mar 27, 2026
Work environment requirements and procedures not documented
- ISO 13485:2016 Clause 7.3.9Mar 27, 2026
Procedures to control design and development changes not documented
- ISO 13485:2016 Clause 7.3.10Mar 27, 2026
Design and development files not maintained
- ISO 13485:2016 Clause 7.4.1Mar 27, 2026
Supplier performance not monitored
- ISO 13485:2016 Clause 7.5.1Mar 27, 2026
Medical device or batch records not adequate
- ISO 13485:2016 Clause 7.5.6Mar 27, 2026
Records of validation of processes and necessary actions not maintained
- ISO 13485:2016 Clause 8.2.2Mar 27, 2026
Complaint handling records not maintained
- ISO 13485:2016 Clause 8.2.4Mar 27, 2026
Internal audits not conducted to ensure QMS meets requirements and is effective
- ISO 13485:2016 Clause 8.2.6Mar 27, 2026
Evidence of conformity to the acceptance criteria not maintained
- ISO 13485:2016 Clause 8.3.1Mar 27, 2026
Nonconforming product not identified and controlled
- ISO 13485:2016 Clause 8.3.1Mar 27, 2026
Records of nonconforming product and actions taken not maintained
- ISO 13485:2016 Clause 8.5.2Mar 27, 2026
Corrective action not taken
Compliance actions
1 on file
Import refusals
0 on file
No import refusals on file for this FEI number.