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

Janssen Research & Development, LLC underwent an FDA surveillance inspection from November 13 to November 21, 2017, in Spring House, PA. The inspection, conducted under guidance for sponsors and contract research organizations (CPG 7348.810), focused on their Phase III clinical trial (ARN-509-003) for Apalutamide. The primary finding, documented in an FDA Form 483, highlighted that an investigator at clinical study site 3400 consistently failed to adhere to the signed agreement, investigational plan, and regulatory requirements (21 CFR 312.56(b)), without prompt intervention or termination by the sponsor. Specific issues at this site included the Principal Investigator's frequent absence during monitoring visits, a participant receiving expired investigational product, significant delays in data entry and sample shipments, missed re-consenting, and numerous protocol deviations. Discussions at the close-out meeting also revealed that the Clinical Study Report understated major protocol deviations related to Grade 3 Hypertension, and a validation summary report for data transfer was absent. Janssen Research & Development, LLC committed to providing a written response within 15 business days to address these observations.