FDA 483 - Hach Co - April 01, 2025

An FDA inspection of Hach Co in Ames, IA, identified a significant deficiency in the firm's corrective and preventive action (CAPA) procedures. The company failed to adequately address ongoing and recurring complaints regarding a speaker error in its CM 130 ultra-low chlorine analyzer, a device used for dialysis treatment. Despite a previous field action and numerous subsequent complaints, no additional corrective actions were initiated, indicating a systemic breakdown in their quality management system.