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BioWorld - Thursday, March 28, 2024
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» FDA hits COVID test maker for lack of marketing authorization, quality management lapses
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FDA hits COVID test maker for lack of marketing authorization, quality management lapses
Jan. 10, 2023
By
Mark McCarty
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U.S. FDA warning letters for medical devices are relatively rare these days, and the Oct. 6, 2022, warning to Empowered Diagnostics LLC of Pompano Beach, Fla., suggests that COVID tests are still front and center where FDA enforcement is concerned.
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