FDA 483 - MRS Ortho LLC - July 10, 2025

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.