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483
•Han C. Phan, M.D.•April 5, 2024

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

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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.

Company
Han C. Phan, M.D.
Inspection Date
April 5, 2024
Product Type
Drugs
Office
Atlanta District Office
People
  • Cheryl A. Grandinetti (investigator)
  • Ann B. Borromeo (investigator)
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ID · 3d5f61f8-d330-45fd-80bb-6211f0579a1d

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