FDA 483 - Experimur, A Frontage Company - March 10, 2023

An FDA inspection of Experimur, A Frontage Company's non-clinical laboratory in Chicago, IL, revealed significant deficiencies. Observations included failures in quality assurance to document deviations from protocols, inadequate data recording practices, and unrevised standard operating procedures concerning study methods and reagent management. These issues indicate a lack of control over data quality and integrity in non-clinical studies.