FDA 483 - Margaret A. Chang, MD, MS - April 25, 2025

Margaret A. Chang, MD, MS, a clinical investigator in Sacramento, CA, was issued a Form FDA 483 following an inspection that revealed significant deficiencies in the conduct of a clinical investigation. The inspection found failures to report adverse events and manage protocol deviations according to the investigational plan. Additionally, the firm failed to prepare and maintain adequate and accurate case histories, including instances of delayed documentation for critical study data.