FDA EIR - Janssen Research & Development, LLC - August 19, 2015

An FDA inspection of Janssen Research & Development, LLC, a subsidiary of Johnson & Johnson, was conducted from August 18-19, 2015, at their Spring House, PA facility. This pre-approval inspection, part of the Bioresearch Monitoring Compliance Program, focused on the company's role as a sponsor/monitor for two clinical studies (protocols 54767414MMY2002 and JNJ54767414GEN501) supporting a Biologics License Application (BLA 761036) for Daratumumab. The regulatory oversight aimed to ensure adherence to Good Clinical Practice (GCP) standards. During the inspection, the FDA reviewed documentation including monitoring reports from U.S. clinical sites, standard operating procedures for various aspects of site management, clinical site training records, and financial disclosures from investigators. Crucially, the inspection concluded with no verbal or written observations, meaning no deficiencies or violations were identified. This outcome signifies compliance with regulatory requirements at the time of the inspection, requiring no specific actions from the company. The report noted a previous inspection in 2010, under a different company name, resulted in an FDA-483 observation related to monitoring, but this issue was not present in the current review.