FDA Issues First Warning Letter for Product With a COVID-19-Related EUA

By Sam | November 6, 2020

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.
Source: The GMP Letter

Posted in The GMP Letter