FDA 483 - Elite BioFusion LLC - September 29, 2023

An FDA inspection conducted at Elite BioFusion LLC from August 18, 2023, to September 29, 2023, identified significant deficiencies in the company’s operations related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The inspection, focused on HCT/P storage, labeling, and distribution, revealed three main observations concerning adherence to regulatory requirements. Firstly, the company lacked established procedures and release criteria for the receipt, shipment, and distribution of HCT/Ps, specifically (b)(4) Stem Cell HCT/Ps. This deficiency meant Elite BioFusion LLC could not provide a complete historical record of work performed for distributed products between October 2019 and June 2021. Secondly, the firm's quality program was found to be inadequate, failing to include essential procedures for receiving, investigating, evaluating, and documenting information related to core Current Good Tissue Practice (CGTP) requirements, including complaint handling. The CEO confirmed the absence of such procedures, which are crucial for preventing the spread of communicable diseases. Lastly, Elite BioFusion LLC's records management system was deemed insufficient, as it could not promptly identify or retrieve necessary records. Key documentation for HCT/P receipt and distribution was stored off-site on an inaccessible personal computer, preventing inspectors from reviewing complete product histories. These observations highlight the need for Elite BioFusion LLC to implement comprehensive procedures and a robust quality and records management system to comply with HCT/P regulations and ensure product safety and traceability.