FDA 483 - Endologix LLC - February 20, 2020

Endologix Inc., a medical device manufacturer in Irvine, CA, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant issues across its quality system, including inadequate corrective and preventive actions, deficient complaint handling, failures in design verification, and insufficient control over non-conforming products and device tracking. These observations indicate a systemic breakdown in ensuring product quality and patient safety.