CellRight Technologies LLCMarch 15, 2019

FDA 483 - CellRight Technologies LLC - March 15, 2019

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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.

Company: CellRight Technologies LLC
Inspection Date: March 15, 2019
Product Type: Biologics
Office: Dallas District Office
People: Everard A. Irish (investigator)
Kathleen B. Swat (Supervisory)

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ID · 61c10834-8fb6-4d80-8fa8-d6f8219d616a