FDA EIR - Artivion, Inc - August 29, 2023

The FDA conducted an unannounced, comprehensive inspection of Artivion, Inc., in Kennesaw, GA, from August 21 to August 29, 2023. This inspection focused on the company's human cells and tissue products (HCT/Ps) and adherence to current Good Tissue Practice (cGTP) requirements, under Compliance Program 7341.002 for HCT/Ps. Investigators extensively reviewed records covering donor screening, tissue processing, packaging, labeling, storage, and distribution, alongside environmental controls and quality systems. Direct observations of key operational areas were also performed. Crucially, the inspection concluded without significant deviations from regulatory requirements. As a result, an FDA-483 Inspectional Observation form was not issued, and no physical or documentary samples were collected. The company's management was noted as cooperative. Given the absence of significant deviations, no specific corrective actions were mandated from this inspection, indicating that the firm's operations reviewed were found to be in compliance with applicable HCT/P regulations and cGTP.