FDA 483 - Garth O. Vaz, M.D. - February 01, 2019

JVC Clinical Research, a clinical investigator site in Gonzales, TX, was inspected regarding two clinical investigations. The inspection revealed a significant failure to adhere to investigational plans, specifically concerning the (b) (4) dosing and dose adjustment algorithms for study subjects. Furthermore, the Principal Investigator did not document the clinical circumstances when deviating from the established dosing protocols.