FDA 483 - Unified Spine, Llc - March 01, 2024

An FDA inspection of Unified Spine, LLC in Westerville, OH, a specification developer of spinal medical devices, revealed three significant observations. The firm was cited for inadequate procedures related to design changes, specifically lacking verification/validation for a screw spinal system update. Additionally, the inspection found deficiencies in supplier control, as the firm failed to routinely evaluate contractors or establish quality agreements for manufacturing its spinal systems. Finally, document control procedures were deemed inadequate, with a significant number of quality system procedures not being approved by "Unified Management" as required.