# FDA 483 - Digirad Corporation - November 25, 2025

Source: https://www.globalkeysolutions.net/records/483/digirad-corporation/f1a0e74b-7513-4886-a9a2-a6dd5bb75824

> FDA 483 for Digirad Corporation on November 25, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Digirad Corporation
- Inspection Date: 2025-11-25
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: 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.

## Related Officers

- [Jenny L. Chisem](https://www.globalkeysolutions.net/people/jenny-l-chisem/d9c3fada-4f08-4f1a-9c6c-06a3c521534c)

Company: https://www.globalkeysolutions.net/companies/digirad-corporation/8c21578c-8aed-43b2-9434-6155a60291ef

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b