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483
•Digirad Corporation•November 25, 2025

Digirad Corporation – FDA 483, Nov 25, 2025

Record Details

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.

Company
Digirad Corporation
Inspection date
November 25, 2025
Product type
device
Office
Los Angeles District Office
Person
  • Jenny L. Chisem
View Company Profile

ID · f1a0e74b-7513-4886-a9a2-a6dd5bb75824

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