# FDA 483 - Tisgenx, Inc. - May 29, 2025

Source: https://www.keypedia.com/records/483/tisgenx-inc/b0175b55-2c21-4502-a4bd-5a5193dc188e

> FDA 483 for Tisgenx, Inc. on May 29, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Tisgenx, Inc.
- Inspection Date: 2025-05-29
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Tigenix, Inc. in Irvine, CA, identified a significant compliance issue related to device identification. The firm failed to submit unique device identifier (UDI) information for its devices to the FDA's Global Unique Device Identification Database (GUDID). This indicates a lapse in regulatory data submission for device traceability.

## Related Officers

- [Jae H. Lee](https://www.keypedia.com/people/jae-h-lee/ce701294-2a54-48f2-8a34-e93231bc2d88)
- [Investigator](https://www.keypedia.com/people/alexandria-l-capuano/f76c710a-613f-42b2-8958-1292fa329112)

Company: https://www.keypedia.com/companies/tisgenx-inc/d387fadc-e65b-49c8-b802-579e2d898285

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