FDA 483 - Mandeep Garewal - June 26, 2017

An FDA inspection of Mandeep Garewal, M.D., Clinical Investigator in Ormond Beach, FL, revealed a significant deviation from investigational plans. Clinical Dementia Rating testing for two protocols was not performed by trained raters as required, with an untrained employee performing the tests while the sub-investigator physician signed the forms. This indicates a serious issue with adherence to study protocols and data integrity.