DSCSA 2025 Compliance Checklist for FDA Enforcement - Jekson Vision
jeksonvision.com
May 8, 2026, 5:53 p.m.
The Drug Supply Chain Security Act (DSCSA) enforcement is now active, requiring immediate compliance from US pharmaceutical manufacturers, contract packagers, and logistics providers. Organizations must implement audit-ready serialization and traceability systems with compliant 2D Data Matrix barcodes on saleable units, establish accurate parent-child hierarchies across serialized units, cases, and pallets, and maintain enterprise-level reporting through L3/L4 systems. Critical requirements include serial number management, EPCIS event data integration, ERP connectivity, and comprehensive audit trails. With FDA enforcement underway and compliance deadlines passed, companies must urgently assess current capabilities, identify gaps, and ensure validated US packaging formats and trained operators are in place before inspections or trading partner rejections occur.