483
CellRight Technologies LLCCellRight Technologies LLC – FDA 483, Mar 15, 2019
Record Details
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.
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ID · 61c10834-8fb6-4d80-8fa8-d6f8219d616a
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