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Home » OUS device makers on FDA’s short list for warning letters
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OUS device makers on FDA’s short list for warning letters

Feb. 10, 2023
By Mark McCarty
It may still be true that a majority of medical devices are manufactured in the U.S., but that doesn’t stop the FDA from dropping a warning letter on facilities located outside the U.S. (OUS). In one of these warning letters, Microvention Inc., of Aliso Viejo, Calif., received a warning letter for its plant in Costa Rica, although the FDA waited until the second week of February to post the Sept. 30, 2022, warning.
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