FDA 483 - Endologix LLC - August 03, 2021

An FDA inspection of Endologix LLC in Irvine, CA, revealed significant deficiencies in its quality system for medical device manufacturing. The firm failed to submit numerous MDRs within the required timeframe and did not adequately investigate device complaints, including those involving serious injuries and death. Additionally, issues were found in the establishment and documentation of corrective and preventive actions, acceptance activities, equipment calibration, and process validation for its AFX and Ovation IX endovascular systems.