Device establishmentActive, RegisteredFDA warning letter on file
NEUROSYNC, INC.
NEUROSYNC, INC. is an FDA-registered device establishment (FEI 3014133165) located in Holliston, Massachusetts. The facility is active, registered. Its most recent FDA inspection on record (2025-02-05) was classified OAI. FDA has issued 1 warning letter(s) to this facility.
FDA warning letter
A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.
Recalls (1)
Recall data from openFDA enforcement reports (FDA Recall Enterprise System).
Establishment record
Inspection history
Jun 20, 2019 · Voluntary Action Indicated (VAI)
Jun 20, 2019 · No Action Indicated (NAI)
Jun 20, 2019, 5 observations: Investigation of device failures; Documented evaluation; Documentation
FDA record timeline
Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.
Questions
Is NEUROSYNC, INC. registered with the FDA?
Yes. NEUROSYNC, INC. is an FDA-registered device establishment (FEI 3014133165) in Holliston, Massachusetts. Its current registration status is Active, Registered.
Has NEUROSYNC, INC. received an FDA warning letter?
Yes. FDA issued a warning letter to NEUROSYNC, INC.; the most recent is dated May 9, 2025 (CGMP/QSR/Medical Devices/Adulterated).
What does NEUROSYNC, INC. do?
NEUROSYNC, INC.'s FDA-registered operations are: Neurology, Manufacture Medical Device.
Related facilities
Source: FDA public data · status as of 2026-08-22