# FDA 483 - Brain Tunnelgenix Technologies - January 31, 2025

Source: https://www.keypedia.com/records/483/brain-tunnelgenix-technologies/2edec188-8ff7-4599-af00-8cb1fa3e0a82

> FDA 483 for Brain Tunnelgenix Technologies on January 31, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brain Tunnelgenix Technologies
- Inspection Date: 2025-01-31
- Product Type: device
- Office Name: Florida District Office
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/ronald-ifraimov/b4ce8b79-3fa2-4862-b7a4-68e14e45d87a)

Company: https://www.keypedia.com/companies/brain-tunnelgenix-technologies/6eeb272d-5d03-4ada-bc79-c1509a9e9aa8

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9