FDA 483 - Han C. Phan, M.D. - April 05, 2024

An FDA inspection of Han C. Phan, M.D., a clinical investigator in Brookhaven, GA, revealed significant deficiencies in record-keeping. The firm failed to prepare or maintain adequate case histories for a clinical study. Specifically, electronic source records or certified copies were missing or unavailable for screening visit assessments for 12 out of 42 enrolled subjects, indicating a serious data integrity issue.