FDA 483 - Kite Pharma, Inc. - November 01, 2024

Kite Pharma, Inc. in Frederick, MD, a finished product drug manufacturer, was inspected by the FDA. The inspection revealed a significant issue with the timely reporting of adverse experiences. Specifically, 11 serious and unexpected adverse experiences were not reported to the FDA within the required 15 calendar days, with delays ranging from 17 to 159 days.