FDA WARNING_LETTER - Exactech, Inc. - July 25, 2025

FDA WARNING_LETTER for Exactech, Inc. on July 25, 2025. Product: devices. Access full analysis and detailed observations.

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Record Summary

FDA WARNING_LETTER for Exactech, Inc. on July 25, 2025. Product: devices. Access full analysis and detailed observations.

Violation Codes

FD&C Act 501(h)

21 CFR 820.25(b)

21 CFR 820.100(a)

21 CFR 820.70(c)

FD&C Act 201(h)

21 CFR 820

21 U.S.C. 321(h)

21 CFR 820.70(a)

21 CFR 820.90(a)

21 CFR 820.80(a)

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Record Information

Company

Exactech, Inc.

Inspection Date

July 25, 2025

Product Type

devices

Office

Center for Devices and Radiological Health

People

ID: 43ec8064-a2fb-467e-89be-2f6aa976a8a3

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