FDA 483 - Janssen Vaccines Corporation - November 19, 2024

An FDA inspection of Janssen Vaccines Corporation in Incheon, Korea, revealed five significant observations concerning their drug product manufacturing operations. The firm failed to adhere to procedures for reporting product quality complaints and demonstrated deficiencies in aseptic processing controls, including unapproved interventions and inadequate operator behavior. Further issues included insufficient environmental monitoring, poor equipment design and cleanliness in aseptic areas, and inadequately qualified integrity testing equipment, collectively indicating a serious lack of control over sterile drug product quality.