ImClone Systems, LLC – FDA 483, Aug 22, 2022

ImClone Systems, LLC in Branchburg, NJ, a drug substance manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included failures to adequately control the disposition of drug substances during deviation investigations and to properly document and investigate deviations from established laboratory procedures. These issues indicate a lack of robust quality unit oversight and adherence to procedural controls.