483
GUIDEMIA TECHNOLOGIES LLCFDA 483 - GUIDEMIA TECHNOLOGIES LLC - July 06, 2026
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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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