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

On November 7, 2024, FDA Investigator Talmane J. Fisher issued a Form FDA 483 to Kalford Fadem, Chief Technology Officer of Neuronetrix Solutions, LLC, a medical device manufacturer located at 1044 E Chestnut St, Louisville, KY. The inspection occurred from November 5-7, 2024.

Two observations were noted: 1. **Inadequate Complaint Review:** Not all complaints were adequately reviewed and evaluated to determine if an investigation was necessary. Specifically, customer support records 16467, 16452, 16405, 16381, and 16276, concerning alleged deficiencies of the Cognision 3000 EEG/ERP system, lacked evidence of an evaluation to determine the necessity of an investigation or the reason for not conducting one. 2. **Failure to Register UDI:** The firm failed to provide the required information to the Global Unique Device Identification Database (GUDID) for the Cognision 3000 EEG/ERP system, specifically failing to register its Unique Device Identification (UDI).

Neuronetrix Solutions, LLC "promised to correct" both observations. The document emphasizes that these are inspectional observations and not a final Agency determination of compliance, and the firm is responsible for internal self-audits to identify and correct all quality system violations.