FDA 483 - Ikonisys Inc. - October 12, 2022

An FDA inspection of Ikonisys Inc. in New Haven, CT, from September 28 to October 12, 2022, revealed significant quality system deficiencies. The firm failed to maintain adequate device history records for its Ikoniscope20 devices, lacking proper traceability and complete documentation. Additionally, the inspection found that nonconforming products were not adequately controlled, indicating a breakdown in their quality assurance processes.