FDA WARNING_LETTER - Neurotris, Inc. dba A1 Engineering - April 25, 2023

FDA WARNING_LETTER for Neurotris, Inc. dba A1 Engineering on April 25, 2023. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Neurotris, Inc. dba A1 Engineering on April 25, 2023. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 U.S.C. 360j(g)

21 CFR 820.50(a)

21 CFR 807.81(b)(1)

21 U.S.C. 351(f)(1)(B)

21 CFR 882.5890

21 CFR 820.100

21 U.S.C. 321(h)

21 CFR 820.90(b)(2)

21 CFR 890.5850

21 CFR 890.5525

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Record Information

Company

Neurotris, Inc. dba A1 Engineering

Inspection Date

April 25, 2023

Product Type

Devices

Office

Center for Devices and Radiological Health

People

ID: b0c28870-c95c-4f1a-8b8f-cd77f2356438

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