Kite Pharma, Inc. – FDA EIR, Jun 16, 2017

An FDA pre-license inspection of Kite Pharma, Inc., located in El Segundo, CA, occurred from June 12-16, 2017. The inspection focused on the manufacturing and control systems for Axicabtagene ciloleucel (YESCARTA™), a new personalized cell immunotherapy, under Biologics License Application STN 125643/0. The regulatory review followed the FDA's Six-system Inspection Model for drug manufacturing.The inspection identified four Form FDA 483 observations. Significant issues included deficiencies in the company's change control system, which lacked comprehensive details for justifying, assessing, and communicating changes to regulatory bodies. Inadequate cleaning procedures for specific manufacturing areas were also noted. Furthermore, a quality agreement with a contract organization was deemed insufficient as it did not mandate the sharing or approval of changes that could impact Kite's data or processes. Concerns were also raised regarding aseptic technique during manufacturing operations and the adequacy of sterility sampling practices.Kite Pharma committed to several voluntary corrective actions. These involved revising internal audit procedures to clarify scope and frequency, updating the Biological Product Deviation Reporting process to encompass all product-impacting deviations, strengthening the training program to define training types and effectiveness measurements, and enhancing the recall procedure with specifics on mock recall execution and supplier notification for raw material recalls. Additional efforts were pledged to review and improve aseptic technique and sampling methodologies.