FDA 483 - Kite Pharma, Inc.

An FDA inspection of Kite Pharma, Inc. in El Segundo, CA, from June 12-16, 2017, revealed significant deficiencies in the firm's quality systems. Observations included inadequate written procedures for manufacturing and change control, a lack of validated aseptic processing procedures, and insufficient supplier qualification for critical components. The inspection highlighted several areas requiring improved control over manufacturing processes and quality unit responsibilities.