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

Source: https://www.keypedia.com/records/483/evoqua-water-technologies-south-windsor/86c7adff-9800-4f87-b374-63aeef27153a

> FDA 483 for EVOQUA WATER TECHNOLOGIES - SOUTH WINDSOR on February 04, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EVOQUA WATER TECHNOLOGIES - SOUTH WINDSOR
- Inspection Date: 2025-02-04
- Product Type: device
- Office Name: New England District Office
- Summary: 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.

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Company: https://www.keypedia.com/companies/evoqua-water-technologies-south-windsor/d1020d55-62bc-4031-b1b7-5fed49370d5d

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