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

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.