Diasol Manufacturing Illegal Dialysis Disinfectants: FDA

A 7/21-8/19/2025 FDA inspection at Diasol, Inc., in Phoenix, AZ, found that the company is manufacturing unapproved disinfectants used to disinfect dialysate delivery systems and water purification systems used in hemodialysis to treat patients with renal failures or toxemic conditions. A just-released 1/29 Warning Letter says the firm’s products are adulterated because Diasol does not have an approved PMA or IDE in effect for them. The products are also misbranded because Diasol did not notify FDA of its intent to begin commercial distribution of the devices.

The letter also lists these Quality System Regulation violations:

• failure to adequately establish procedures for finished device acceptance;
• failure to adequately validate a process whose results cannot be fully verified by subsequent inspection and test according to established procedures;
• failure to adequately establish process control procedures that describe any process controls necessary to ensure conformance to specifications;
• failure to appropriately design, construct, and install equipment used in the manufacturing process to facilitate maintenance, adjustment, cleaning, and use;
• failure to suitably design buildings to perform necessary operations;
• failure to adequately establish procedures to control product that does not conform to specified requirements;
• failure to adequately establish procedures for receiving, reviewing, and evaluating complaints by a formally designated unit;
• failure to adequately establish procedures for corrective and preventive action;
• failure to establish a design history file;
• failure to adequately establish procedures for design change;
• failure to adequately establish procedures for design verification;
• failure to adequately establish requirements that must be met by contractors and consultants; and
• failure to perform risk analyses.

The letter says Medical Device Reporting violations were:

• failure to report to FDA required information after receiving or becoming aware of information reasonably suggesting that a marketed device has malfunctioned and it or a similar marketed device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur; and
• failure to adequately develop, maintain, and implement written Medical Device Reporting procedures.

The letter also lists a unique device identifier violation.

Diasol was told to correct the violations promptly and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of each step and a schedule for completing the corrections. FDA also requests that Diasol submit certification on specified dates that an outside expert consultant has audited its manufacturing and quality assurance systems relative to regulatory requirements.