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Home » Innova Draws FDA Warning for COVID-19 Tests, GMP Lapses
Innova Draws FDA Warning for COVID-19 Tests, GMP Lapses
The FDA issued a warning letter to Innova Medical Group in Pasadena, California for false and misleading labeling for its SARS-CoV-2 antigen rapid qualitative test, as well as marketing the test without FDA clearance and a slew of GMP observations at two facilities.