FDA 483 - Mobius Bionics, LLC - November 16, 2022

Mobius Bionics, LLC was issued an FDA Form 483 following an inspection conducted from November 10 to November 16, 2022. The primary observation identified a significant lapse in the company's quality system management. Specifically, executive management failed to review the suitability and effectiveness of the quality system at defined intervals, contrary to their established Management Responsibility Plan (QMS-02-000, Rev. 3). A substantial period elapsed between reviews, with one occurring on October 14, 2020, and the next not until November 7, 2022. This issue is particularly pertinent as Mobius Bionics has been distributing and servicing a Class II medical device since June 2017. The FDA 483 indicates observed conditions and practices that may not comply with the Federal Food, Drug, and Cosmetic Act and associated quality system regulations for medical devices. The document highlights the firm’s responsibility to conduct internal self-audits and implement corrective actions to address these findings and ensure ongoing compliance with quality system requirements.