FDA 483 - Synergy Spine Solutions, Inc. - November 24, 2025

Synergy Spine Solutions, Inc. was inspected regarding a pivotal trial for the Synergy Disc and received a Form 483 with three observations. The inspection revealed significant issues including enrollment of ineligible subjects without proper pregnancy testing, widespread failures in protocol management and reporting to IRBs and FDA, and inaccurate or incomplete study records. These findings indicate a serious lack of oversight and compliance in the conduct of the investigational device study.