FDA 483 - Culligan Soft Water Service Co - July 14, 2023

Culligan Soft Water Service Co in Minnetonka, MN, was inspected and cited for multiple quality system deficiencies related to the manufacture and servicing of deionizer and activated carbon tanks for dialysis water. Key issues include inadequate procedures for non-conforming product, corrective and preventive actions, personnel training, equipment calibration and maintenance, and service verification. The findings indicate a systemic breakdown in maintaining a compliant quality system.