FDA 483 - Darrell White, M.D. - October 19, 2015

An FDA inspection of Darrell White, M.D., a clinical investigator in Halifax Nova Scotia, revealed a significant deviation from the investigational plan. Specifically, vital signs were not consistently taken during elotuzumab infusion treatments for subjects, and a required premedication was not administered as specified in the protocol. These issues indicate a failure to ensure the investigation was conducted according to the established plan.