FDA 483 - Healthcare Logistics Systems, LLC, D/B/A Healthcare Logiix Systems - April 02, 2025

An FDA inspection of Healthcare Logistics Systems, LLC, d/b/a Healthcare Logiix Systems, a medical device manufacturer in Coral Springs, FL, revealed significant deficiencies in their quality system. The firm failed to establish essential procedures for complaint handling, corrective and preventive actions, and servicing activities. These findings indicate a fundamental lack of documented processes for critical quality management functions.