FDA 483 - ImClone Systems, LLC - August 21, 2020

ImClone Systems, L.L.C. in Branchburg, NJ, a biological drug substance manufacturer, was cited for significant quality system and laboratory control deficiencies. The firm failed to thoroughly investigate unexplained discrepancies and batch failures, often misclassifying serious GMP violations as minor observations. Additionally, laboratory controls lacked scientifically sound and consistent test procedures for drug substances, leading to uncontrolled and irreproducible purity method results.