FDA 483 - EVOQUA WATER TECHNOLOGIES - SOUTH WINDSOR - February 04, 2025

An FDA inspection of Evoqua Water Technologies LLC in South Windsor, CT, revealed significant deficiencies in quality system procedures for medical devices. Observations included failures in complaint handling, inadequate process and environmental control procedures, and issues with device history records and document control. These findings indicate a need for improved adherence to regulatory requirements for medical device manufacturing.