FDA 483 - Insite One - October 31, 2025

InsiteOne, LLC, a software manufacturer in Wallingford, CT, received a Form FDA 483 for inadequate complaint handling procedures. The firm failed to adequately establish procedures for receiving, reviewing, and evaluating complaints, specifically by not determining if complaints were reportable as Medical Device Reports (MDRs). This indicates a deficiency in their quality system regarding post-market surveillance.