FDA EIR - Janssen Research & Development, LLC - February 04, 2019

A routine FDA inspection of Janssen Research & Development, LLC was conducted from January 22 to February 4, 2019, in Titusville, NJ. The inspection aimed to assess the company's compliance with applicable regulations, specifically the Sponsor, Contract Research Organizations and Monitors Compliance Program Guidance Manual (CPGM) 7348.810, across three clinical protocols for intranasal Esketamine in treatment-resistant depression. Despite a comprehensive review of operational aspects, including training, SOPs, vendor oversight, and data management, the inspection concluded without the issuance of a Form FDA 483, Inspectional Observations, indicating no significant regulatory violations requiring formal action. However, the inspection highlighted several operational challenges that Janssen was actively addressing. These included a notable number of intranasal device malfunctions leading to partial dose delivery for subjects, and instances where clinical investigators at one site failed to properly oversee drug dispensing, resulting in unrecorded partial doses. Another issue involved the administration of an incorrect investigational product kit at a different site. Initial discrepancies in electronic data audit trails were also noted but were clarified during the inspection. Janssen responded to these findings by implementing internal retraining for site staff on device usage and administration procedures, and conducting ongoing investigations into device complaints and administration errors. No specific corrective actions were formally mandated by the FDA in this report.