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BRAINSPEC, INC — FDA Facility Profile

FEI 3035371452

BRAINSPEC, INC is an FDA-registered facility (FEI 3035371452) located in Framingham, MA, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Jun 24, 2026: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Jun 24, 2026Voluntary Action Indicated (VAI)Preventive action procedures not documented (ISO 13485:2016 Clause 8.5.3)

Facility details

Company
BRAINSPEC, INC
Location
Framingham, MA (US)
Source
device

FDA data resources

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