Janssen Research & Development, LLC – FDA EIR, Feb 27, 2017

An FDA comprehensive surveillance inspection of Janssen Research & Development, LLC, located in Spring House, PA, was conducted from February 23 to February 27, 2017. The inspection focused on the company's role as a sponsor for clinical trials related to the investigational product sirukumab, a human anti-IL-6 monoclonal antibody for active rheumatoid arthritis. This review was performed under Compliance Program 7348.810, which governs Sponsor/Monitor and Contract Research Organization activities, specifically for Premarket BLA Original, Application Number BLA 761057.

The inspection encompassed a thorough review of study documentation, including monitoring plans and reports, test article accountability, Institutional Review Board (IRB) approvals, adverse event reporting, and the transfer of obligations agreement with the contract research organization. Financial disclosure documents from all involved investigators and sub-investigators were also examined.

Notably, the inspection concluded without any observations of non-compliance. No FDA-483 form, which outlines inspectional observations, was issued, nor were any discussions regarding deficiencies held with management. This outcome indicates a "No Action Indicated" classification, signifying that no significant violations or issues were identified during this comprehensive assessment. Consequently, no specific corrective actions were required from Janssen Research & Development, LLC following this inspection.