FDA 483 - Juno Therapeutics, Inc. - September 20, 2023

Juno Therapeutics, Inc. in Bothell, WA, received a Form 483 following an inspection from September 11-20, 2023, for its cell therapy manufacturing. The inspection revealed significant deficiencies in aseptic processing, quality control unit procedures for complaint handling, and adherence to written procedures for equipment maintenance. These observations indicate a need for improved adherence to established manufacturing and quality systems.