483
Han C. Phan, M.D.FDA 483 - Han C. Phan, M.D. - April 05, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · 3d5f61f8-d330-45fd-80bb-6211f0579a1d