FDA WARNING_LETTER - Envoy - July 02, 2025

FDA WARNING_LETTER for Envoy on July 02, 2025. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Envoy on July 02, 2025. Product: Devices. Access full analysis and detailed observations.

Violation Codes

FD&C Act 501(h)

21 CFR 820.100(a)

FD&C Act 201(h)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.198(a)

21 U.S.C. 351(h)

21 CFR 820.30(g)

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Record Information

Company

Envoy

Inspection Date

July 2, 2025

Product Type

Devices

Office

Office of Regulatory Programs

People

Barbara A. Marsden (Acting Director)

ID: f7b07158-7710-4086-9595-72528fdf09d1

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