FDA WARNING_LETTER - Diasol, Inc - August 19, 2025

The FDA issued a Warning Letter to Diasol, Inc. following an inspection from July 21 to August 19, 2025, at their Phoenix, AZ facility, which manufactures disinfectants and concentrates for hemodialysis systems. The company was cited for significant violations of the Federal Food, Drug, and Cosmetic Act and the Quality System Regulation (21 CFR Part 820) for medical devices. A primary issue involved the firm marketing unapproved solutions of Citric Acid (50% and 20%) for cleaning and disinfection of hemodialysis machines without the required FDA premarket approval or clearance, rendering these products adulterated and misbranded. Further extensive violations of Quality System Regulations included failures in: establishing adequate procedures for finished device acceptance, leading to non-compliant product specifications and untested batches; validating critical manufacturing processes such as drum cleaning, mixing, and water purification; implementing appropriate process controls for water quality and warehouse environmental conditions; maintaining equipment and facilities, with observed leaks, inoperable systems, and structural deterioration; effectively controlling nonconforming products, including a lack of proper investigation into out-of-specification results; establishing suitable complaint handling procedures, failing to classify product replacements as complaints or evaluate for Medical Device Reporting; and implementing effective Corrective and Preventive Actions, resulting in recurring deficiencies. Diasol, Inc. is required to implement comprehensive, documented corrective actions to address these systemic issues, ensuring full compliance with FDA regulations. The FDA deemed many of the company's initial responses inadequate, emphasizing the need for robust verification of all implemented changes.