ImClone Systems, LLC – FDA EIR, Jul 10, 2015

The FDA conducted a routine inspection of ImClone Systems, LLC d.b.a. Eli Lilly and Company's Branchburg, NJ facility from July 7-10, 2015. This inspection, focused on therapeutic biologics drug substance manufacturing, adhered to Compliance Programs 7356.002A (Sterile Drug Process Inspections) and 7356.002M (Inspections of Licensed Biological Therapeutic Drug Products), with specific coverage of the Quality and Laboratory Controls systems. Throughout the four-day assessment, no significant issues were identified that would necessitate the issuance of an FDA Form 483, "Inspectional Observations." While the company largely demonstrated compliance, a minor administrative discrepancy was noted regarding a contractor's annual Good Manufacturing Practice (GMP) training record, which incorrectly listed both GMP and non-GMP work areas. This was promptly investigated and corrected by management during the inspection. Additionally, two Out-of-Specification laboratory investigations had exceeded their standard completion timelines, but the firm had properly documented and secured approvals for extensions. The inspection concluded without any formal observations or mandated corrective actions, affirming the facility's satisfactory adherence to current Good Manufacturing Practices for its commercial production of drug substances for products such as Erbitux and Cyramza.