# FDA 483 - Targeted Genomics, LLC - March 26, 2026

Source: https://www.keypedia.com/records/483/targeted-genomics-llc/4da76e2d-ebd6-436e-a47c-87990340c59d

> FDA 483 for Targeted Genomics, LLC on March 26, 2026. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Targeted Genomics, LLC
- Inspection Date: 2026-03-26
- Product Type: other
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Targeted Genomics, LLC in Irvine, CA, a manufacturer of genetic testing kits, revealed two significant observations. The firm failed to apply a risk-based approach to its quality management system, specifically lacking a required FMEA for its Class II GlutenID Genetic Health Risk Test. Additionally, controls over outsourced processes for assembling and distributing genetic testing kits were not proportionate to the risk, with inadequate supplier qualification and monitoring procedures for a critical supplier.

## Related Officers

- [Richard E. Evoy](https://www.keypedia.com/people/richard-e-evoy/31c4827c-e0dc-4ddf-b516-714209b2515d)
- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.keypedia.com/companies/targeted-genomics-llc/e7cd5a9d-6cd7-42fb-9a35-53c9a23c1856

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