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Home » FDA Issues First Warning Letter for Product With a COVID-19-Related EUA
FDA Issues First Warning Letter for Product With a COVID-19-Related EUA
FDA hit Columbus, Ohio-based Battelle Memorial Institute with a warning letter for failure to comply with terms of its Emergency Use Authorization (EUA) for its decontamination system used for N95 respirators. This marks the first warning letter FDA has sent out regarding a product with a COVID-19-related EUA.
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