FDA WARNING_LETTER - NeuroSync, Inc. - February 05, 2025

FDA WARNING_LETTER for NeuroSync, Inc. on February 05, 2025. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for NeuroSync, Inc. on February 05, 2025. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 801.40(a)(2)

21 U.S.C. 352(t)(2)

21 CFR 820.30(a)

21 CFR 820.30(i)

21 CFR 820

21 U.S.C. 321(h)

21 U.S.C. 352(c)

21 CFR 801.40(a)(1)

21 CFR 820.80(a)

21 CFR 820.30(c)

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Record Information

Company

NeuroSync, Inc.

Inspection Date

February 5, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Matthew G. Hillebrenner

ID: 407f9de3-8676-477c-b52a-7f678fd90b43

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