FDA EIR - Sattva S. Neelapu, M.D. - July 28, 2017

An FDA inspection of Clinical Investigator Dr. Sattva S. Neelapu, M.D., at the University of Texas MD Anderson Cancer Center in Houston, TX, was conducted from July 24-28, 2017. The inspection evaluated the conduct of study KTE-C19-101 (ZUMA-1) under Compliance Program 7348.811, pertaining to Clinical Investigators and Sponsor-Investigators, linked to Kite Pharma Inc.'s Biologics License Application (BLA) #125643 and IND #16278. While no official Form FDA 483 was issued, the FDA noted several observations. Key issues included numerous deficiencies in conducting neurological assessments as per protocol, specifically missed assessments and those performed by untrained or undelegated personnel. Additionally, the inspection identified a delayed administration of a quality of life questionnaire for one subject, which occurred after other screening activities, and delayed laboratory testing for the initial enrolled subject. The site acknowledged these observations and promised corrective actions. The FDA informed the site of potential legal sanctions if voluntary preventive measures are not implemented and provided an option for a written response, though the site does not intend to respond formally unless requested.