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 deficiencies in their investigational plan execution. The facility failed to adequately document subject files, maintain proper drug accountability, control study drug storage temperatures, and ensure staff were properly trained in Good Clinical Practice. These issues indicate a broad lack of adherence to regulatory requirements for clinical trials.