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BioWorld - Sunday, July 12, 2026
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Home » Device makers back on US FDA’s warning letter radar screen
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Device makers back on US FDA’s warning letter radar screen

March 18, 2024
By Mark McCarty
The U.S. FDA posted two warning letters to device makers in the second week of March 2024, one each to Exactech Inc., of Gainesville, Fla., and the other to Nobles Medical Technology II Inc., of Fountain Valley, Calif. The themes of these warnings are entirely different, with Noble receiving a warning regarding clinical trial oversight and Exactech taking a hit for routine good manufacturing compliance issues, showing that the FDA is active in the post-COVID compliance realm.
Medical technology Regulatory Cardiovascular Orthopedics U.S. FDA

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