Brain Tunnelgenix TechnologiesJanuary 31, 2025

FDA 483 - Brain Tunnelgenix Technologies - January 31, 2025

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Record Details

An FDA inspection of Brain Tunnelgenix Technologies in Aventura, FL, from January 27-31, 2025, identified one observation. The firm was cited for not maintaining records of complaint investigations within the formally designated unit. Complaints related to devices were documented in patient charts rather than on a separate complaint form, contrary to their established procedure.

Company: Brain Tunnelgenix Technologies
Inspection Date: January 31, 2025
Product Type: Device
Office: Florida District Office
Person: Ronald Ifraimov (investigator)

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