Today FDA announced it has issued a warning letter to Battelle Memorial Institute for failing to comply with reporting requirements related to its Critical Care Decontamination System. The firm’s decontamination system received FDA emergency use authorization (EUA) in March due to its stated ability to decontaminate N95 respirators up to 20 times. According to FDA’s public statement, the agency “determined that Battelle Memorial Institute does not have adverse event reporting processes in accordance with Title 21 Code of Federal Regulations Part 803 (21 CFR 803), in place, as required by the EUA.”
In August FDA sent a letter to Battelle asking for more information related to its process for submitting reportable adverse events to the agency after it was made aware that there could be deficiencies in Battelle’s process. “In this letter, the FDA provided examples of reportable events that may be relevant to the authorized product including allergic reactions or eye, mouth or nose irritation, evidence that a decontaminated respirator is unable to perform its essential function, events related to hydrogen peroxide residuals or user contact with hydrogen peroxide residuals, infection in respirator wearers, or malfunctions of the generator used to decontaminate the respirators,” according to FDA’s press release.
Battelle has 15 working days to provide information to the agency as to how it will correct the violations.