483
Han C. Phan, M.D.Han C. Phan, M.D. – FDA 483, Apr 5, 2024
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.
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ID · 3d5f61f8-d330-45fd-80bb-6211f0579a1d
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