FDA 483 - Medtronic Xomed, Inc. - June 17, 2024

During an inspection, Medtronic Xomed, Inc. in Jacksonville, FL, was cited for inadequately established corrective and preventive action procedures. Specifically, an ineffective CAPA related to an EMG tube cuff overinflation complaint demonstrated a failure in root cause analysis and the implementation of effective corrective measures, leading to recurring issues.