FDA EIR - Travere Therapeutics, Inc. - June 23, 2022

An FDA inspection of Travere Therapeutics Inc., located in San Diego, CA, was conducted from June 20 to June 23, 2022. This preannounced inspection was part of a Prescription Drug User Fee Act (PDUFA) review for an original New Drug Application (NDA), adhering to Compliance Program 7348.810 for Sponsors, Contract Research Organizations, and Monitors. The primary objective was to verify the integrity of data supporting the application and assess compliance with FDA requirements for selecting and monitoring clinical investigators, adverse event reporting, test article accountability, and data handling. The inspection also covered the blinding plan due to the application's accelerated approval pathway. Importantly, the FDA found "no significant objectionable conditions or practices" during the inspection, and therefore, no FDA-483 form, which lists observed deficiencies, was issued. This indicates that Travere Therapeutics Inc. demonstrated satisfactory adherence to regulatory requirements for the aspects reviewed, and no immediate corrective actions were required by the FDA. The inspection concluded with a general discussion with management.