Rho, Inc. – FDA EIR, Jun 30, 2017

An FDA inspection of Contract Research Organization Rho, Inc. took place at their Chapel Hill, NC facility from June 26-30, 2017. This audit focused on Rho’s responsibilities for New Drug Application (NDA) 209311, specifically studies HLD200-107 and HLD200-108. The inspection identified critical issues, leading to an FDA-483 observation for failure to conduct investigations in accordance with IND protocols, as per 21 CFR 312.50. The primary violation involved Rho’s Interactive Web Response System (IWRS) for Study HLD200-107. The system permitted multiple randomizations for six subjects at Site 15, resulting in all subjects in a specific cohort receiving active Investigational Product (IP), contrary to the study’s randomization schedule. This error stemmed from the IWRS not saving randomization events until kits were assigned, coupled with inadequate placebo kit supply at the site. Additionally, Rho erroneously sent initial IP shipments instead of double-blind supplies to four sites, causing inventory shortages and necessitating problematic site-to-site transfers. Further concerns were raised regarding electronic data management, including the deletion of interim data files and insufficient access to complete audit trails for completed studies. The FDA also noted deficiencies in Rho’s procedures for escalating and tracking serious issues, specifically a lack of robust Corrective and Preventive Action (CAPA) management and non-adherence to internal standard operating procedures. The recurring identification of inadequate staffing and training as root causes for deviations indicated potential systemic quality management weaknesses. Rho management received the FDA-483 and committed to responding with corrective actions within 15 business days.