# FDA 483 - Elevate Textiles, Inc. - April 11, 2025

Source: https://www.keypedia.com/records/483/elevate-textiles-inc/de587903-bcfe-47f8-9d3b-01ddacb331f3

> FDA 483 for Elevate Textiles, Inc. on April 11, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elevate Textiles, Inc.
- Inspection Date: 2025-04-11
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Elevate Textiles, Inc. in Burlington, NC, received a Form FDA 483 with six observations related to significant deficiencies in its quality system for Class II medical devices. The firm failed to establish and implement critical quality procedures, including design controls, CAPA, training documentation, and quality audits, despite manufacturing having commenced. These issues indicate a fundamental lack of a compliant quality management system.

## Related Officers

- [Christopher B. May](https://www.keypedia.com/people/christopher-b-may/b2173a59-d37b-41f1-aa39-eefd854722b8)

Company: https://www.keypedia.com/companies/elevate-textiles-inc/b6839d73-6dda-4b74-a690-8ed59a0a94fe

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7