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My DashboardInspection TrackerWarning LettersExactech, Inc. dba Advita Ortho

All Warning Letters

Exactech, Inc. dba Advita Ortho

Warning LetterOpen

Recipient Title President and Chief Executive Officer, Exactech, Inc. dba Advita Ortho, 2320 Nw 66th Ct Gainesville , FL 32653-1630 United StatesIssued Dec 19, 2025Center for Devices and Radiological Health

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations7

Issue DateDec 19, 2025

Product TypeMedical Devices

StatusOpen

Letter Details

Firm: Exactech, Inc. dba Advita Ortho
Location: Recipient Title President and Chief Executive Officer, Exactech, Inc. dba Advita Ortho, 2320 Nw 66th Ct Gainesville , FL 32653-1630 United States
FEI Number: N/A
Country: United States
Issue Date: December 19, 2025
Issuing Office: Center for Devices and Radiological Health
Product Type: Medical Devices
Status: Open

Subject

CGMP/QSR/Medical Devices/Adulterated

Exactech, Inc. dba Advita Ortho FDA Warning Letter, December 19, 2025