FDA 483 - Digirad Corporation - November 25, 2025

Digirad Diagnostic Imaging, LLC in Poway, CA, was inspected by the FDA from November 19-25, 2025, revealing issues with their quality system. The inspection found deficiencies in supplier quality management, specifically regarding the use of non-conformance records in supplier evaluations, and inadequate procedures for equipment calibration and maintenance. These observations indicate a need for improved adherence to established quality control procedures.