483
Tisgenx, Inc.FDA 483 - Tisgenx, Inc. - May 29, 2025
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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.
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ID · b0175b55-2c21-4502-a4bd-5a5193dc188e