FDA 483 - Huiqiang Sun Huang - February 14, 2025

An FDA inspection of Yet-Sen University Cancer Center's clinical research facility in Guangzhou, China, revealed significant deviations from its investigational plan. Deficiencies included inadequate subject file documentation, improper study drug handling and storage, and insufficient staff training in Good Clinical Practice. These findings indicate a systemic failure to adhere to proper clinical trial procedures, potentially impacting subject safety and data integrity.