483
KB MEDICAL (GROUP), INC.KB MEDICAL (GROUP), INC. – FDA 483, May 21, 2025
Record Details
An FDA inspection of KB MEDICAL (GROUP), INC. in Irvine, CA, a specification developer, identified one significant observation. 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 compliance regarding device identification and tracking.
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