FDA 483 - Kite Pharma, Inc. - August 27, 2025

Kite Pharma, Inc. in El Segundo, CA, received a Form 483 citing four observations during an FDA inspection. The findings highlight significant deficiencies in record-keeping, computer system validation, process control procedures, and sanitation documentation. These issues indicate a need for improved adherence to Good Manufacturing Practices across critical manufacturing and quality control operations.