FDA 483 - GSource, LLC - July 30, 2024

GSource, LLC in Emerson, NJ, a medical device repacker/relabeler/manufacturer, was cited for two significant issues during an FDA inspection. The firm's Medical Device Reporting (MDR) procedure lacked a standardized review process for determining reportable events. Additionally, procedures for receiving and investigating customer complaints were inadequate, failing to properly trend device malfunctions like recurring drill bit breakages across product families.