FDA 483 - Omnia Medical - July 28, 2025

An FDA inspection conducted at Omnia Medical from July 17-28, 2025, identified critical deficiencies in the company's manufacturing and quality control processes for its TiBrid SA System, a standalone intervertebral body fusion device. The main violations centered on three key areas. Firstly, Omnia Medical failed to report significant device corrections and removals to the FDA. The company initiated design changes and advised customers to return instrument kits (flex drivers and awls) due to breakage and malfunction issues, which were deemed to pose a potential risk to health. Despite these actions, required written reports were not submitted. Secondly, the firm's risk analysis for the TiBrid SA System was found to be inadequate and incomplete. It failed to comprehensively assess the risk, probability of occurrence, mitigation efforts, or potential patient harm associated with instrument malfunctions, and crucial Health Hazard Evaluations were not performed for design changes. Lastly, procedures for controlling environmental conditions within the ISO Class 7 clean room, used for packaging the TiBrid SA implant, were not established, potentially impacting product quality. To achieve compliance with regulatory standards, Omnia Medical must implement corrective actions, including proper reporting of device issues, comprehensive risk assessments, and establishing adequate environmental controls.