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# Summary Cue Health, Inc. received a warning letter regarding manufacturing and quality system compliance violations for its Cue Health COVID-19 Test products, which are authorized diagnostic devices under Emergency Use Authorizations. The FDA conducted an inspection between October 17 and November 3, 2023, at the company's San Diego facility and identified Current Good Manufacturing Practice (CGMP) and Quality System Regulation (QSR) deficiencies that rendered the devices adulterated. The letter addressed both the laboratory-authorized version (EUA200248) and the home/over-the-counter version (EUA210180) of the COVID-19 test.