FDA 483 - CellRight Technologies LLC - March 15, 2019

An FDA inspection of CellRight Technologies LLC in Universal City, TX, identified a significant deviation related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P). The firm failed to report a deviation where an expired serology testing tube was used for a donor whose tissue products were subsequently distributed. This indicates a lapse in compliance with Current Good Tissue Practice (CGTP) reporting requirements.