483
MRS Ortho LLCFDA 483 - MRS Ortho LLC - July 10, 2025
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Record Details
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.
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