FDA Inspection
BRAINCHECK, INC.BRAINCHECK, INC. – FDA Inspection, Sep 18, 2025
Record Details
This FDA Inspection record concerns BRAINCHECK, INC., with an inspection on September 18, 2025, issued by the Dallas District Office, covering medical devices & rad health.
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ID · 545fb316-bb6a-4943-ad0d-25946b21e692
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1282178
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of BRAINCHECK, INC.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 12, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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