FDA 483 - Janssen Biotech, Inc - September 27, 2024

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from September 9 to September 27, 2024, at Janssen Biotech, Inc.'s corporate office in Titusville, NJ, an observation was made regarding the company's compliance with its Risk Evaluation and Mitigation Strategy (REMS). The primary issue identified was the company's failure to adhere to the audit plan and schedule outlined in its approved REMS Implementation System. Specifically, initial and/or subsequent audits of certain authorized wholesalers/distributors, including AmerisourceBergen, McKesson, and Cardinal, as well as certified pharmacies, were not completed within the required timelines. For instance, an initial audit for AmerisourceBergen, an authorized distributor, was delayed by several months past its due date, despite the audit questionnaire being received earlier. Similarly, a certified pharmacy's initial and subsequent audits for Tecvayli or Talvey distribution also significantly exceeded their respective deadlines. This observation indicates a deviation from the regulatory framework governing product safety and risk management, as mandated by the approved REMS. While the FDA 483 document itself serves as an inspectional observation and not a final determination, Janssen Biotech, Inc. is expected to address these findings. The company has the opportunity to discuss any objections or submit plans for corrective actions to resolve the identified compliance issues related to their REMS program.