KITE PHARMA INC – FDA EIR, Jan 28, 2022

An FDA inspection of Kite Pharma, Inc. in Santa Monica, CA, was conducted from January 24 to 28, 2022. This comprehensive review, carried out under the Bioresearch Monitoring Compliance Program 7348.810, evaluated the company's adherence to Good Clinical Practice standards as a sponsor of the ZUMA-7 clinical trial. The inspection covered various areas, including clinical investigator forms, study monitoring reports, ClinicalTrials.gov compliance, quality assurance, investigational product accountability, and electronic systems.

A key observation, though not resulting in a Form FDA 483 (Inspectional Observations), was the absence of documented rationale for the selection and qualification of two specific outsourced service vendors. This highlighted the necessity for thorough record retention concerning clinical trial documentation. In response to management discussions, Kite Pharma implemented a new internal procedure (FRM-16506) to formally document the selection rationale for all future study-related vendors. Otherwise, the inspection found no notable issues regarding clinical investigator selection and oversight, monitoring activities, data handling, safety reporting, or financial disclosures, affirming the company's general commitment to regulatory compliance.