# FDA 483 - Neuronetrix Solutions, LLC - November 07, 2024

Source: https://www.globalkeysolutions.net/records/483/neuronetrix-solutions-llc/da263747-7e6a-4d54-9c0f-48ce456bd148

> FDA 483 for Neuronetrix Solutions, LLC on November 07, 2024. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neuronetrix Solutions, LLC
- Inspection Date: 2024-11-07
- Product Type: Devices
- Office Name: Cincinnati District Office
- Summary: Neuronetrix Solutions, LLC, located in Louisville, KY, underwent an FDA inspection from November 5 to November 7, 2024. The inspection revealed two primary compliance issues. First, the company failed to adequately review and evaluate customer complaints related to their Cognision 3000 EEG/ERP system to determine if investigations were necessary. Specific complaint records, including numbers 16467, 16452, 16405, 16381, and 16276, lacked documentation of evaluations or reasons for not conducting investigations.

Second, Neuronetrix Solutions did not comply with the requirement to register the unique device identification (UDI) for the Cognision 3000 EEG/ERP system in the Global Unique Device Identification Database (GUDID). This omission violates the regulatory framework mandating that each medical device version or model bear a UDI.

The FDA's observations, documented in Form FDA 483, are not final determinations of compliance but highlight areas needing corrective action. Neuronetrix Solutions is responsible for conducting internal audits to address and rectify these violations. The company has committed to correcting the noted deficiencies. For further guidance, Neuronetrix Solutions can contact the FDA office in Cincinnati, OH.

## Related Documents

- [483 - 2022-11-07](https://www.globalkeysolutions.net/records/483/neuronetrix-solutions-llc/e4a19e74-9828-4f88-8ba2-1be902b66dff)
- [483 - 2024-11-07](https://www.globalkeysolutions.net/records/483/neuronetrix-solutions-llc/f3e9a32a-58fe-4bb1-a731-c148b0496b8a)

## Related Officers

- [Talmane J. Fisher](https://www.globalkeysolutions.net/people/talmane-j-fisher/f69c101f-fbc7-4ca1-a6d1-1e25450c52b7)

Company: https://www.globalkeysolutions.net/companies/neuronetrix-solutions-llc/0d8ea998-36a4-47ea-9061-2b9c227fded5

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22