# FDA 483 - Diagnostic Automation/Cortez Diagnostics Inc - July 15, 2021

Source: https://www.keypedia.com/records/483/diagnostic-automationcortez-diagnostics-inc/534524bf-1a8f-4cf3-a02e-b3634d8706d2

> FDA 483 for Diagnostic Automation/Cortez Diagnostics Inc on July 15, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Diagnostic Automation/Cortez Diagnostics Inc
- Inspection Date: 2021-07-15
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Diagnostic Automation/Cortez Diagnostics Inc. in Irvine, CA, underwent an FDA inspection from July 13-15, 2021, which revealed a significant deficiency in their process control procedures. The firm failed to adequately establish procedures for recording in-process non-conformities during the relabeling/repacking of Class II IVD kits. This indicates a moderate severity issue related to quality system compliance.

## Related Officers

- [investigator](https://www.keypedia.com/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.keypedia.com/companies/diagnostic-automationcortez-diagnostics-inc/1780f851-4e22-43ef-818f-eaff1fa4bef1

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6