FDA 483 - Eminent Spine, LLC - October 13, 2023

Eminent Spine, LLC, a manufacturer/specification developer in Plano, TX, received a Form FDA 483 with three observations. The inspection revealed significant deficiencies in purchasing controls and quality agreements with contract manufacturers, inadequate risk analysis for its 3D Lumbar IBFD - PLIF product, and a deficient Medical Device Reporting procedure that led to unreported serious injuries. These issues indicate a lack of robust quality system controls.