Warning Letter — Nipro Renal Solutions USA, Corporation
The FDA issued a Warning Letter to Nipro Renal Solutions USA, Corporation on July 24, 2026, following an evaluation by the Center for Devices and Radiological Health.
Nipro Renal Solutions USA, Corporation, and regulatory professionals involved in the oversight of renal care medical devices and related quality systems.
A Warning Letter from CDRH indicates that the firm's responses to previous inspectional findings were likely insufficient to address regulatory concerns. This development suggests potential systemic issues in quality control or regulatory compliance that could lead to further enforcement actions if not remediated.
Review Quality Management System (QMS) records to ensure all documentation satisfies Center for Devices and Radiological Health (CDRH) standards; verify that corrective actions have been fully implemented and documented following recent inspections.
FDA Warning Letter issued to: Nipro Renal Solutions USA, Corporation. 07/24/2026 — Center for Devices and Radiological Health. Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nipro-renal-solutions-usa-corporation-732874-07242026
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