FDA EIR - Janssen Pharmaceuticals Inc. - January 22, 2016

An FDA inspection of Janssen Pharmaceuticals, Inc., located in Raritan, NJ, was conducted from January 14-22, 2016. The inspection focused on the company's consumer complaint handling and pharmacovigilance activities for prescription drugs like Remicade and Risperdal Consta, stemming from a previous PADE inspection and a specific consumer complaint. While no formal FDA-483 observations were issued, discussions with management highlighted several areas for improvement. Prior to May 2014, "Lack of Effect" complaints, particularly those without lot numbers, were not consistently forwarded for product quality investigations. This led to a subsequent global increase in reported product quality complaints after a communication reinforced procedural requirements. Furthermore, the Central Complaint Vigilance (CCV) group did not consistently monitor whether complaints forwarded to other release groups were properly handled or completed. A significant issue was that findings from monthly complaint monitoring were not always distributed to all relevant departments; only the scheduled responsible group reviewed their specific findings, potentially leaving other departmental issues unaddressed. Janssen management acknowledged these points and indicated they are implementing changes to their complaint management process, including a new platform and structure to enhance monitoring and management of forwarded complaints. They also committed to evaluating and improving the distribution of monitoring findings to ensure all relevant groups address identified issues.