FDA WARNING_LETTER - Avertix Medical, Inc. - March 11, 2025

FDA WARNING_LETTER for Avertix Medical, Inc. on March 11, 2025. Product: devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Avertix Medical, Inc. on March 11, 2025. Product: devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.50(a)

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

21 CFR 803.3(o)(2)(i)

21 CFR 803.17(a)(3)

21 CFR 820.100(a)

21 CFR 803.50(a)(1)

21 CFR 803.3(w)

21 CFR 803.12(a)

21 CFR 820

21 U.S.C. 321(h)

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Record Information

Company

Avertix Medical, Inc.

Inspection Date

March 11, 2025

Product Type

devices

Office

Center for Devices and Radiological Health

People

ID: 500a7617-dcde-4ce9-b469-ac7ff0141ee1

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