FDA 483 - Kite Pharma, Inc. - August 20, 2019

Kite Pharma Inc. in El Segundo, CA, was cited with three observations during an FDA inspection of its biologic cell therapy facility. The observations relate to deficiencies in establishing the accuracy of test methods, failure to report biological product deviations within the required timeframe, and not following written production and process control procedures. These issues indicate a lack of robust quality control and adherence to established protocols in their manufacturing operations.