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

Janssen Biotech, Inc. in Titusville, NJ, was cited for failing to comply with the audit plan and schedule outlined in its approved Risk Evaluation and Mitigation Strategy (REMS) Implementation System. The inspection revealed that initial and subsequent audits for authorized distributors and certified pharmacies, including those handling Tecvayli or Talvey, were not completed by their due dates. This indicates a significant lapse in adhering to established risk management protocols.