FDA 483 - Legacy Ortho LLC - October 29, 2024

An FDA inspection, conducted from October 22 to October 29, 2024, at an unspecified facility, identified four significant observations related to its handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The inspection, performed by Investigator Jennifer L Sheehan, highlighted critical deficiencies in adherence to Current Good Tissue Practice (CGTP) requirements. The primary issues observed centered on inadequate record-keeping and a systemic lack of established written procedures. Specifically, the firm failed to record essential information for HCT/Ps stored on site. Furthermore, comprehensive standard operating procedures were not in place for various core manufacturing steps involving HCT/Ps, including specific processing activities. A notable omission was the absence of established procedures for handling complaints, which is a fundamental CGTP requirement. The inspection also revealed a lack of documented procedures for other key activities related to HCT/Ps. These observations underscore a need for the firm to implement robust quality system improvements. This includes developing and formalizing comprehensive documentation practices and establishing clear, written procedures across all HCT/P operations to ensure regulatory compliance. The firm is expected to address these findings with appropriate corrective actions.