FDA 483 - Kite Pharma, Inc. - October 22, 2021

Kite Pharma Inc. in El Segundo, CA, received a Form 483 with two observations. The inspection revealed deficiencies in environmental monitoring within aseptic processing areas, specifically regarding the placement and requirement for active viable air sampling in Biological Safety Cabinets. Additionally, the firm failed to promptly perform investigations into serious and unexpected adverse events related to product infections reported via MedWatch.