FDA 483 - Intelligent Technologies LLC - September 19, 2024

Intelligent Technologies LLC, a manufacturer in San Diego, CA, was inspected by the FDA from September 16-19, 2024, resulting in two observations. The inspection revealed deficiencies in equipment calibration procedures, specifically regarding a missing calibration sticker on a thermometer, and inadequate complaint handling procedures that lacked required investigation criteria. These issues indicate a need for improved quality system controls.