NeuroOne Medical Technologies CorporationOctober 28, 2024

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

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore NeuroOne Medical Technologies Corporation

Record Details

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.

Company: NeuroOne Medical Technologies Corporation
Inspection Date: October 28, 2024
Product Type: Device
Office: Minneapolis District Office
People: Alicia U. Jacobo
Christina L. Bigham (Investigator )

Open in Dashboard

ID · 22a88808-b6aa-4107-b30d-dbd575144e58