FDA EIR - Janssen Research & Development, LLC - November 21, 2017

An FDA surveillance inspection of Janssen Research & Development, LLC, conducted from November 13-21, 2017, focused on their New Drug Application (NDA) 210951 for Apalutamide. The inspection, guided by CPG 7348.810 for Sponsors and Contract Research Organizations, identified significant compliance issues at a key clinical trial site (Site #3400), leading to a single observation on Form FDA 483. The main violation, referencing 21 CFR 312.56(b), concerned the sponsor's failure to promptly ensure compliance or terminate an investigator who did not adhere to the study agreement and regulatory requirements. Repeated problems at Site #3400 included the Principal Investigator's frequent unavailability during monitoring visits, inadequate oversight of the consent process, significant delays in data entry and query resolution, improper handling of investigational product (e.g., expired drug use), and delayed shipment of critical samples. The site accumulated 83 protocol deviations, including four major ones, and 14 Corrective and Preventive Action (CAPA) plans were initiated. Additionally, discussions at the close-out meeting highlighted that several similar medical events (Grade 3 Hypertension) were not consistently reported as major protocol deviations in the Clinical Study Report, and a data transfer validation summary report was absent. Janssen Research & Development, LLC committed to providing a written response to the FDA's findings within 15 business days.