FDA 483 - ImClone Systems, LLC - November 26, 2019

ImClone Systems, L.L.C. in Branchburg, NJ, a biological drug substance manufacturer, was cited for significant data integrity issues during an FDA inspection. The firm failed to exercise appropriate controls over computer systems in both its manufacturing production and Quality Control laboratory environments. These deficiencies included deleted audit trails, unreviewed data, and inadequate access controls, indicating a serious lack of oversight for critical data used in producing drug substances distributed in the U.S. market.