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

Nipro Renal Solutions USA, Corporation, located in Lewisberry, Pennsylvania, received an FDA Warning Letter following an inspection conducted from February 2 to March 27, 2026. The FDA concluded that the company"s manufacturing of hemodialysis dialysate solutions violated the Federal Food, Drug, and Cosmetic Act and the Quality Management System Regulation. Significant issues were identified regarding the release and distribution of products that failed safety tests for endotoxins, which pose a potential risk of adverse reactions in patients. The company also failed to properly investigate these failures or document nonconforming products. Additional violations included ineffective corrective actions that led to recurring problems such as residue on machinery and leaking pipes, a lack of design history records for marketed devices, and the use of uncalibrated testing equipment. Furthermore, the FDA noted that Nipro failed to comply with Unique Device Identification (UDI) requirements, specifically by omitting required identification labels and failing to submit necessary product information to the national database. The FDA found Nipro’s previous attempts to address these issues inadequate. The company is required to respond within 15 business days with a detailed plan and timeline for corrective actions, including evidence that these measures effectively prevent future violations. Failure to comply may result in regulatory actions such as product seizures, legal injunctions, or financial penalties.