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

During an inspection conducted from October 28 to November 1, 2024, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Kite Pharma, Inc., a finished product drug manufacturer located in Frederick, MD. The inspection identified a significant issue regarding the timely reporting of adverse experiences. The primary observation noted that the company failed to report all adverse experiences within the required 15 calendar days of initial receipt of the information. Specifically, between March 2022 and October 2024, eleven serious and unexpected adverse experiences were not submitted to the FDA within the mandated timeframe. These reports were delayed, arriving at the FDA between 17 and 159 calendar days after the initial receipt of the information by Kite Pharma. This observation indicates a deficiency in the company's adherence to regulatory requirements for post-market surveillance and pharmacovigilance for drug products. As a result, Kite Pharma, Inc. is expected to promptly review and address these identified issues, implementing corrective actions to ensure timely and compliant reporting of all adverse drug experiences in accordance with federal regulations.