FDA 483 - Nipro Renal Soultions USA, Corporation - March 27, 2026

Nipro Renal Solutions USA, Corporation, a medical device manufacturer in Lewisberry, PA, was cited for significant quality system deficiencies during an FDA inspection. The observations primarily concern inadequate control of nonconforming product, lack of proper design control and change management, failures in corrective and preventive actions, and widespread issues with maintenance, validation, and record-keeping for critical manufacturing processes and equipment. These issues indicate a systemic breakdown in the firm's quality management system, potentially impacting the safety and efficacy of their hemodialysis products.