FDA WARNING_LETTER - Miach Orthopaedics - April 23, 2025

FDA WARNING_LETTER for Miach Orthopaedics on April 23, 2025. Product: Devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Miach Orthopaedics on April 23, 2025. Product: Devices. Access full analysis and detailed observations.

Violation Codes

21 CFR 820.75(b)

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

21 CFR 820.50(a)(1)

21 CFR 820.250(b)

21 CFR 820.100(a)

21 CFR 803.50(a)(1)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.90(a)

21 CFR 820.198(a)

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Record Information

Company

Miach Orthopaedics

Inspection Date

April 23, 2025

Product Type

Devices

Office

Center for Devices and Radiological Health

People

Matthew G. Hillebrenner

ID: 36f3af34-e281-4fa1-8ac8-cdc34b649e3c

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