FDA EIR - Kite Pharma, Inc. - August 20, 2019

An FDA Level 1 GMP inspection of Kite Pharma, Inc., a manufacturer of licensed biological products (CAR-T cells like YESCARTA®), was conducted from August 12-20, 2019. This was the firm's first post-market GMP inspection since its U.S. FDA licensure in October 2017, conducted under the OBPO/Team Biologics FY19 work plan and Compliance Program 7345.848. The comprehensive review covered Quality, Production, Facilities & Equipment, Materials, Laboratory, and Packaging & Labeling systems. At the inspection's conclusion, Kite Pharma was issued a FORM FDA 483, documenting three objectionable conditions. These included a lack of assurance regarding the proper assessment of the potency method's accuracy, the failure to report a 2018 timepoint failure as a biological product deviation, and the absence of initial verification for a supplier's test results according to established procedures. Management committed to providing a written response detailing corrective actions to the U.S. FDA.