FDA 483 - ALOM Technologies Corporation - October 17, 2024

ALOM Technologies Corporation in Indianapolis, IN, was inspected by the FDA from October 15-17, 2024. The inspection revealed that the firm's procedures for corrective and preventive action (CAPA) were not adequately established. This led to undocumented changes in their inventory management system and Device History Record documentation, indicating deficiencies in their quality system controls.