FDA 483 - Erika P. Hamilton, MD - May 12, 2017

An FDA inspection of Erika P. Hamilton, MD in Nashville, TN, a clinical investigator, revealed that an investigation was not conducted in accordance with the investigational plan. Specifically, four out of 17 enrolled subjects received incorrect dosing diaries, leading to potential deviations in drug administration instructions. This indicates a significant issue with protocol adherence and subject management during the clinical trial.