483
INFLAMMATIX INCINFLAMMATIX INC – FDA 483, Apr 30, 2026
Record Details
An FDA inspection of INFLAMMATIX INC in Sunnyvale, CA, identified a single observation related to regulatory compliance for medical devices. The firm failed to provide correct unique device identifier (UDI) information to the Global Unique Device Identification Database (GUDID) for its Myma and Triverity devices. This lapse occurred prior to the commercial distribution of these devices, indicating a significant regulatory oversight.
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ID · e30d800c-942c-4c0a-8efd-6d1f9e52db02
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