Hans C. Lee, M.D.January 10, 2020

FDA 483 - Hans C. Lee, M.D. - January 10, 2020

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Record Details

An FDA inspection of Hans Lee, M.D., a clinical investigator in Houston, TX, revealed a significant deviation from the investigational plan. The firm failed to properly conduct an investigation, specifically regarding the incorrect dosing of multiple subjects in a study. This resulted in at least 7 out of 15 subjects receiving improper study drug dosages, contrary to the protocol's requirements for holding or reducing the drug.

Company: Hans C. Lee, M.D.
Inspection Date: January 10, 2020
Product Type: Drugs
Office: Dallas District Office
Person: Andrea A. Branche (CSO)

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