FDA EIR - VIRTUS PHARMACEUTICALS LLC. - February 01, 2018

An FDA Postmarketing Adverse Drug Experience (PADE) inspection of Virtus Pharmaceuticals, LLC, based in Newtown, PA, took place from January 23 to February 1, 2018. The inspection, guided by regulatory frameworks for PADE reporting, focused on the company's system for adverse drug experience surveillance, receipt, evaluation, processing, and reporting for various marketed products. The inspection identified four main violations, documented on Form FDA-483. Firstly, Virtus lacked written procedures for the surveillance and internal receipt of postmarketing adverse drug experiences from all sources, including methods for reviewing, approving, and reconciling cases with their pharmacovigilance service contractor. Secondly, the company failed to submit all quarterly periodic adverse drug experience reports within the required 30 days (e.g., Acarbose, Tranexamic Acid Injection). Thirdly, annual periodic reports, such as for Prometrium, were not submitted within the mandated 60 days of the application’s approval anniversary. Lastly, quarterly periodic reports for non-alert adverse drug experiences were not submitted for certain applications approved less than three years prior (e.g., Dapsone, Acarbose). In response, management acknowledged the observations and committed to developing comprehensive Standard Operating Procedures for handling adverse events. They also pledged to ensure timely submission of all required safety reports, reconcile data with pharmacovigilance contractors, and implement basic adverse event training for all relevant employees and affiliates. Virtus Pharmaceuticals was instructed to provide a written response and action plan to the FDA within fifteen business days.