FDA 483 - Chao-Ming C. Lu, MD - August 13, 2021

An FDA inspection of Chao-Ming C. Lu, Clinical Investigator, in Hacienda Heights, CA, revealed significant deficiencies in clinical investigation practices. The inspection cited failures in maintaining adequate and accurate case histories, including informed consent documentation and numerous date discrepancies. Additionally, issues were found with investigational drug disposition records and adherence to the investigational plan, specifically regarding the timely reporting of serious adverse events.