# FDA 483 - NeuroOne Medical Technologies Corporation - October 28, 2024

Source: https://www.keypedia.com/records/483/neuroone-medical-technologies-corporation/22a88808-b6aa-4107-b30d-dbd575144e58

> FDA 483 for NeuroOne Medical Technologies Corporation on October 28, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NeuroOne Medical Technologies Corporation
- Inspection Date: 2024-10-28
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: NeuroOne Medical Technologies Corporation in Eden Prairie, MN, was inspected by the FDA, resulting in two observations. The inspection revealed deficiencies in the firm's design validation procedures, including inadequate implementation of its product development process and unvalidated test methods. Additionally, the firm's risk analysis was found to be inadequate, with inconsistencies in severity definitions and unassessed product specifications.

## Related Officers

- [Alicia U. Jacobo](https://www.keypedia.com/people/alicia-u-jacobo/5f75a995-c0df-4615-be88-d401df48ad26)
- [Investigator ](https://www.keypedia.com/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.keypedia.com/companies/neuroone-medical-technologies-corporation/9b0d5e64-3353-43e0-83b5-8383d1545cb5

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d