FDA 483 - Eugene Chang - September 01, 2023

An FDA inspection of Eugene Chang, a clinical investigator in Glendora, CA, revealed a significant deficiency related to the conduct of a clinical study. The firm failed to conduct investigations in accordance with the signed statement of investigator, specifically noting multiple instances where subjects' required laboratory testing was not performed as mandated by the study protocol. This indicates a serious deviation from established study procedures and good clinical practice.