FDA Inspection 1280338 — Nipro Renal Soultions USA, Corporation
The FDA completed an inspection of Nipro Renal Soultions USA, Corporation on March 27, 2026 in Lewisberry, PA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 27, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lewisberry, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23019 | ISO 13485:2016 Clause 4.1.2 | Risk-based approach not applied to QMS processes |
| 23036 | ISO 13485:2016 Clause 4.2.3 | Medical device file not established and maintained |
| 23078 | ISO 13485:2016 Clause 6.3 | Maintenance records not maintained |
| 23080 | ISO 13485:2016 Clause 6.4.1 | Work environment requirements and procedures not documented |
| 23130 | ISO 13485:2016 Clause 7.3.9 | Procedures to control design and development changes not documented |
| 23136 | ISO 13485:2016 Clause 7.3.10 | Design and development files not maintained |
| 23142 | ISO 13485:2016 Clause 7.4.1 | Supplier performance not monitored |
| 23157 | ISO 13485:2016 Clause 7.5.1 | Medical device or batch records not adequate |
| 23174 | ISO 13485:2016 Clause 7.5.6 | Records of validation of processes and necessary actions not maintained |
| 23219 | ISO 13485:2016 Clause 8.2.2 | Complaint handling records not maintained |
| 23220 | ISO 13485:2016 Clause 8.2.4 | Internal audits not conducted to ensure QMS meets requirements and is effective |
| 23231 | ISO 13485:2016 Clause 8.2.6 | Evidence of conformity to the acceptance criteria not maintained |
| 23236 | ISO 13485:2016 Clause 8.3.1 | Nonconforming product not identified and controlled |
| 23239 | ISO 13485:2016 Clause 8.3.1 | Records of nonconforming product and actions taken not maintained |
| 23255 | ISO 13485:2016 Clause 8.5.2 | Corrective action not taken |