FDA 483 - Diasol, Inc - August 19, 2025

The FDA issued a Form 483 to Diasol, Inc. with 18 observations, many of which are repeat findings from previous inspections. The firm demonstrated significant deficiencies across its quality system, including inadequate procedures for finished device acceptance, unvalidated manufacturing processes, insufficient process controls, and poorly maintained equipment and facilities. Additionally, the inspection revealed failures in nonconforming product control, complaint handling, MDR reporting, CAPA, design control, and document control, indicating a systemic lack of effective corrective actions.