FDA 483 - Lakhi Sakhrani - February 05, 2016

An FDA inspection of Lakhi Sakhrani, a clinical investigator in San Gabriel, CA, revealed significant deficiencies in conducting clinical investigations and maintaining accurate records. Observations included failure to follow the investigational plan, such as not reporting required lab results due to samples exceeding stability and not suspending subject dosing as instructed. Additionally, widespread inaccuracies and omissions were found in case histories, concomitant medication reporting, adverse event reporting, and study drug accountability within the eCRF system.