FDA 483 - Johnson & Johnson Consumer, Inc - March 24, 2021

Johnson & Johnson Consumer, Inc. in Lancaster, PA, a drug manufacturer, was cited for failing to thoroughly review batch failures and their components. Specifically, the firm's investigation reports for Imodium Multi-Symptom Relief tablet compression and yield deviations were inadequate in assessing root causes and implementing effective corrective and preventative actions. This indicates a significant lapse in quality control and investigation processes.