FDA Inspection
Nipro Renal Soultions USA, CorporationNipro Renal Soultions USA, Corporation – FDA Inspection, Mar 27, 2026
Record Details
This FDA Inspection record concerns Nipro Renal Soultions USA, Corporation, with an inspection on March 27, 2026, issued by the Philadelphia District Office, covering medical devices & rad health.
- Inspection Date
- March 27, 2026
- Product Type
- Medical Devices & Rad Health
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ID · dfbb42e0-c3a1-43aa-a7a3-780a2348ee66
Inspection Facts
- Inspection number
- 1280338
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
15- ISO 13485:2016 Clause 4.1.2Risk-based approach not applied to QMS processes
- ISO 13485:2016 Clause 4.2.3Medical device file not established and maintained
- ISO 13485:2016 Clause 6.3Maintenance records not maintained
- ISO 13485:2016 Clause 7.3.10Design and development files not maintained
- ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented
- ISO 13485:2016 Clause 7.4.1Supplier performance not monitored
- ISO 13485:2016 Clause 7.5.1Medical device or batch records not adequate
- ISO 13485:2016 Clause 7.5.6Records of validation of processes and necessary actions not maintained
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
- ISO 13485:2016 Clause 8.2.4Internal audits not conducted to ensure QMS meets requirements and is effective
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Other FDA inspections of Nipro Renal Soultions USA, Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 12, 2019 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 21, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 30, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Nipro Renal Soultions USA, Corporation
- FDA Inspection 1118873 - 2019-11-12
- FDA Inspection 956271 - 2016-01-21
- FDA Inspection 816183 - 2013-01-30
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