FDA 483 - Synapse Dental - November 01, 2021

An FDA inspection of Synapse Dental in Cranston, RI, a specification developer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for design changes, acceptance activities, and complaint handling. These issues indicate a lack of robust controls over product design, incoming materials, and post-market surveillance for their Synapse Dental Pain Eraser device.