# FDA 483 - Suez Treatment Solutions, Inc. - September 16, 2022

Source: https://www.globalkeysolutions.net/records/483/suez-treatment-solutions-inc/2995b0e3-e2b3-4abb-b7b2-4d3b5ca5c5f0

> FDA 483 for Suez Treatment Solutions, Inc. on September 16, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Suez Treatment Solutions, Inc.
- Inspection Date: 2022-09-16
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of Suez Treatment Solutions, Inc. in Arlington, TX, a medical device manufacturer, revealed significant deficiencies across its quality system. The firm failed to adequately establish and follow procedures for process controls, handling of nonconforming products, acceptance activities, and complaint management. These issues indicate a systemic lack of adherence to quality assurance requirements.

## Related Documents

- [483 - 2025-10-17](https://www.globalkeysolutions.net/records/483/suez-treatment-solutions-inc/6bad66b1-d258-4066-842d-09ccd1ddb3d1)

## Related Officers

- [Ellen J. Tave](https://www.globalkeysolutions.net/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

Company: https://www.globalkeysolutions.net/companies/suez-treatment-solutions-inc/9545871f-3e60-486e-9633-aeed9a6c7fd5

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab