FDA 483 - Janssen Pharmaceuticals Inc.

An FDA inspection of Janssen Biopharmaceuticals, Inc. in Raritan, NJ, a lentiviral vector manufacturer, identified two significant observations. The firm was cited for deficient control and maintenance of manufacturing systems, evidenced by numerous events on a manufacturing line. Additionally, investigations into deviations were not initiated in a timely manner, with multiple nonconformance reports exceeding required creation timelines.