# FDA 483 - MRS Ortho LLC - July 10, 2025

Source: https://www.globalkeysolutions.net/records/483/mrs-ortho-llc/a365b35b-c406-459e-a94d-72694d387665

> FDA 483 for MRS Ortho LLC on July 10, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MRS Ortho LLC
- Inspection Date: 2025-07-10
- Product Type: biologics
- Office Name: Dallas District Office
- Summary: An FDA inspection of MRS Ortho LLC, a human tissue distributor in Richardson, TX, revealed significant deficiencies in their handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to evaluate incoming HCT/Ps for microorganisms or inspect them for damage and contamination. Additionally, the company did not retain records for the required 10-year period and failed to record and maintain storage temperatures for HCT/Ps.

## Related Officers

- [Ramon L. Gonzalez-Prieto](https://www.globalkeysolutions.net/people/ramon-l-gonzalez-prieto/f03487d2-7c8c-407f-8270-a838f7a7d127)

Company: https://www.globalkeysolutions.net/companies/mrs-ortho-llc/0e7932c8-a677-44aa-990b-6f7122cd69d8

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