FDA 483 - Axiobionics, LLC - November 22, 2024

Axiobionics, LLC in Ann Arbor, MI, a medical device establishment, was cited for significant quality system deficiencies during an FDA inspection. Observations included a repeat finding for inadequate management reviews, failure to investigate a complaint involving patient burns from a BioShortZ device, and poorly established corrective and preventive action procedures with open CAPAs lacking target dates. These issues indicate a systemic breakdown in maintaining an effective quality management system.