FDA Inspection 1282178 — BRAINCHECK, INC.

BRAINCHECK, INC. — FEI 3014129043

The FDA completed an inspection of BRAINCHECK, INC. on Sep 18, 2025 in Austin, TX. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI)
End Date
Sep 18, 2025
Fiscal Year
2025
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Austin, TX (United States)

Citations

IDCFRDescription
313021 CFR 820.100(a)Lack of or inadequate procedures

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.