KB MEDICAL (GROUP), INC.May 21, 2025

FDA 483 - KB MEDICAL (GROUP), INC. - May 21, 2025

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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.

Company: KB MEDICAL (GROUP), INC.
Inspection Date: May 21, 2025
Product Type: Device
Office: Los Angeles District Office
People: Jae H. Lee
Alexandria L. Capuano (Investigator)

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ID · effb0291-e456-445a-9369-47dca36b4200