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

Evoqua Water Technologies LLC received an FDA Form 483 following an inspection of their South Windsor, CT medical device facility from January 29 to February 4, 2025. The inspection identified several significant quality system deficiencies, indicating non-conformance with FDA's Quality System Regulation (21 CFR Part 820). Key observations included inadequate complaint handling, where device failure complaints were not consistently reviewed or investigated, and evaluations for Medical Device Reporting were incomplete. Process control procedures for specific manufacturing operations were not adequately established, potentially leading to inconsistencies. The firm also failed to maintain complete and accurate Device History Records, with issues such as missing production recipes, unreviewed records, and absent or undocumented quality test results for finished devices. Additionally, environmental control procedures were found deficient, specifically regarding temperature monitoring for water storage tanks. Finally, the inspection noted inadequate document control, as obsolete and uncontrolled documents were found in use for critical sanitization and testing activities. Evoqua Water Technologies LLC is expected to promptly address these observations by implementing comprehensive corrective actions to ensure full regulatory compliance.