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

Kite Pharma, Inc. in Frederick, MD, a finished product drug manufacturer, was cited for failing to report serious and unexpected adverse experiences to the FDA within the required 15 calendar days. The inspection, conducted from October 28 to November 1, 2024, revealed 11 instances where reports were delayed by 17 to 159 days, indicating a significant lapse in regulatory reporting compliance.