# FDA 483 - Nelson Enviromental Technologies, Inc. - June 18, 2025

Source: https://www.keypedia.com/records/483/nelson-enviromental-technologies-inc/3d0ef10a-bd4e-4c6f-bb7a-27d4a65827ca

> FDA 483 for Nelson Enviromental Technologies, Inc. on June 18, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nelson Enviromental Technologies, Inc.
- Inspection Date: 2025-06-18
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Nelson Enviromental Technologies, Inc. in Arlington, TX, revealed significant deficiencies in their quality management system. Observations included inadequate corrective and preventive action procedures, insufficient sampling methods for Class II devices, and incomplete device history records. Additionally, the firm failed to appoint a management representative to oversee quality system requirements.

## Related Documents

- [483 - 2023-10-10](https://www.keypedia.com/records/483/nelson-enviromental-technologies-inc/2e302dd3-959c-4ca2-be4c-b08aff6a37ab)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/roy-baby/69a18ef5-167c-41eb-a57e-3d138a0820c2)
- [Elizabeth A. Krolczyk](https://www.keypedia.com/people/elizabeth-a-krolczyk/ecf57c43-b88d-4f84-962b-9067eaad4a7c)

Company: https://www.keypedia.com/companies/nelson-enviromental-technologies-inc/72923611-aaf9-44a7-9c22-ff9f1dd06061

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9