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

The FDA has hit the Battelle Memorial Institute, a nonprofit applied science and technology development company in Columbus, Ohio, with a warning letter for failing to comply with the terms of an Emergency Use Authorization (EUA) for its decontamination system used for N95 respirators.

The Battelle Critical Care Decontamination System (CCDS), which was granted an EUA in March, is authorized for use in decontaminating compatible N95 respirators for reuse by healthcare personnel when there are insufficient supplies of filtering facepiece respirators.

The FDA cited many reportable adverse events that could be linked to the decontamination system and said the company should have reported them to the agency.