# FDA 483 - Onyx Medical, LLC - February 13, 2026

Source: https://www.keypedia.com/records/483/onyx-medical-llc/c5f36d70-5750-4823-a88a-acbd703315f6

> FDA 483 for Onyx Medical, LLC on February 13, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Onyx Medical, LLC
- Inspection Date: 2026-02-13
- Product Type: device
- Office Name: New Orleans District Office
- Summary: Onyx Medical, LLC dba Elos Medtech, a contract manufacturing facility in Bartlett, TN, was cited for failing to adequately apply a risk-based approach to its quality management system. The inspection revealed deficiencies in applying risk-based controls to quality data analysis, management review processes, and decision-making for critical manufacturing changes. These issues limited management's ability to identify systemic problems and ensure QMS effectiveness, potentially impacting product quality.

## Related Officers

- [Javelle P. Spann](https://www.keypedia.com/people/javelle-p-spann/31a8f7a8-e442-4f5a-b33f-55bfe911e61b)

Company: https://www.keypedia.com/companies/onyx-medical-llc/06737f3d-f7c2-470f-a770-b3fd555b33e9

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea