FDA 483 - ISLAND DENTAL LAB DBA EMERALD DENTAL LAB - March 11, 2025

An FDA inspection of ISLAND DENTAL LAB DBA EMERALD DENTAL LAB in Valley Stream, NY, revealed five significant observations related to its manufacturing of medical devices, specifically the Emerald Herbst device. The firm was cited for deficiencies in establishing procedures for acceptance activities, medical device reporting, corrective and preventive actions, and failing to maintain a complete design history file and upload UDI information to the GUDID database. These issues indicate a lack of adequate quality system controls for medical device manufacturing.