Warning letter
Nipro Renal Solutions USA, Corporation: warning letter of Jul 24, 2026
FDA warning letter 732874 · Center for Devices and Radiological Health
Key facts
| Reference number | 732874 |
|---|---|
| Company | Nipro Renal Solutions USA, Corporation |
| Subject | CGMP/QSR/Medical Devices/Adulterated |
| Issue date | Jul 24, 2026 |
| Posted date | Aug 18, 2026 |
| Issuing office | Center for Devices and Radiological Health |
| Product type | Devices |
| CFR sections cited | 801, 801.3, 801.40(a)(1), 801.40(a)(2), 801.20(a), 820, 830, 830.3, 830.300(a) |
| Inspection city | Lewisberry |
| Inspection ZIP | 17339 |
| Inspection start date | Feb 2, 2026 |
| Letter on fda.gov | fda.gov |
At a glance
- 1–9 CFR sections cited
- OAI Linked inspection classification
- Yes Form FDA 483 issued
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA warning letters
FDA warning letters notify a firm of significant regulatory violations found during an inspection or review and request prompt corrective action.
Source: U.S. Food and Drug Administration (FDA), Warning Letters · Source date: