FDA 483 - Omnia Medical - July 28, 2025

Omnia Medical, a manufacturer of the TiBrid SA System (an intervertebral body fusion system) in Morgantown, WV, was cited for three significant issues during an FDA inspection. The firm failed to report corrections and removals of malfunctioning devices to the FDA, maintained inadequate and incomplete risk analyses for its products, and lacked established procedures for monitoring environmental conditions in its clean room packaging area. These observations indicate deficiencies in device reporting, design controls, and environmental control, posing potential risks to product quality and patient safety.