FDA 483 - Legacy Ortho LLC - October 29, 2024

Legacy Ortho LLC in Mason, OH, received a Form 483 with four observations related to its human tissue establishment. The inspection revealed significant deficiencies in record-keeping and the establishment of core Current Good Tissue Practice (CGTP) procedures, particularly concerning HCT/Ps. These issues indicate a lack of adequate controls for manufacturing, storage, and complaint handling.