FDA 483 - Verastem, Inc. - February 05, 2025

The U.S. Food and Drug Administration (FDA) issued a Form 483 to Verastem, Inc. following an inspection conducted from January 27 to February 5, 2025, at their facility in Needham, MA. The inspection identified a significant observation related to the company's oversight of clinical studies as a sponsor. Specifically, Verastem, Inc. was cited for failing to ensure that a study was conducted in accordance with its approved protocol and investigational plan. A primary concern was the inadequate reporting of study deviations to the FDA. The report highlighted that out of 22 reviewed deviations at one particular site, eight, representing 36%, were not submitted to the agency. An example provided involved a study subject who took an incorrect number of doses, refused to complete a study diary, and missed a scheduled visit, with these critical deviations remaining unreported to the FDA. These findings indicate a lapse in adherence to regulatory requirements for clinical trial conduct and reporting, which falls under the purview of the Federal Food, Drug, and Cosmetic Act. Verastem, Inc. is now expected to review these observations and implement appropriate corrective actions to ensure full compliance and maintain the integrity of its clinical research.