FDA 483 - Elite BioFusion LLC - September 29, 2023

Elite BioFusion LLC in Anaheim, CA, was cited with three observations during an FDA inspection of its HCT/P storage, labeling, and distribution facility. The firm failed to establish adequate procedures for HCT/P receipt, shipment, and distribution, and lacked a comprehensive quality program to address CGTP requirements and complaints, including preventing communicable disease spread. Additionally, the records management system was found to be deficient, with critical records not readily identifiable or retrievable.