483
GUIDEMIA TECHNOLOGIES LLCGUIDEMIA TECHNOLOGIES LLC – FDA 483, Jul 6, 2026
Record Details
An FDA inspection of GUIDEMIA TECHNOLOGIES LLC, a medical device manufacturer in Buena Park, CA, revealed significant quality system deficiencies. The firm failed to adequately maintain records for corrective actions and complaint handling, and lacked proper personnel training. Additionally, the company did not register its devices with the Global Unique Device Identification Database (GUDID).
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ID · 99cb4f89-202c-430c-a55e-440d9af286cb
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