EVOQUA WATER TECHNOLOGIES - SOUTH WINDSORFebruary 4, 2025

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

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore EVOQUA WATER TECHNOLOGIES - SOUTH WINDSOR

Record Details

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.

Company: EVOQUA WATER TECHNOLOGIES - SOUTH WINDSOR
Inspection Date: February 4, 2025
Product Type: Device
Office: New England District Office
Person: Jeffrey J. Thibodeau (Power Trader/Data Scientist)

Open in Dashboard

ID · 86c7adff-9800-4f87-b374-63aeef27153a