Tisgenx, Inc.May 29, 2025

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

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Record Details

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.

Company: Tisgenx, Inc.
Inspection Date: May 29, 2025
Product Type: Device
Office: Los Angeles District Office
People: Jae H. Lee
Alexandria L. Capuano (Investigator)

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ID · b0175b55-2c21-4502-a4bd-5a5193dc188e