FDA 483 - Jiyu Wen - September 22, 2023

An FDA inspection of Affiliated Hospital of Guangdong Medical University in Zhanjiang, China, revealed significant deviations from its investigational plan during a clinical study. Deficiencies included subjects being screened before obtaining informed consent, inadequate record-keeping for CT images and ECG reports, and improper management of investigational medical products. The findings indicate a failure to adhere to Good Clinical Practice.