UDI Data Inconsistencies Triggering FDA Warnings and Import Blocks

$100,000-$300,000 per incident (label reprinting, inventory write-off, delay penalties); annual cost ~$30,000-$60,000 for manual QA reconciliation and failed batches • $100K-$300K annual loss from audit delays, remediation costs, procurement holds, mandatory rework of device inventory records, federal penalties for non-compliance • $120K-$350K annual loss from import delays, slow inventory turnover, regional compliance penalties, lost sales due to stock unavailability

Auditor team manually samples devices and cross-references UDI against GUDID in Excel workbooks; creates audit exception reports; escalates manufacturer compliance issues to federal contracting officer; requests manufacturers remediate GUDID submissions • Complaint handling staff manually cross-reference device serial number with UDI barcode image; contact distributor/manufacturer to verify correct UDI; maintain parallel tracking spreadsheet for unresolved complaints • Complaint staff maintain shadow database in Excel correlating GPO UDI vs. manufacturer UDI vs. member hospital inventory; manual outreach to members via email/phone to identify affected hospitals; escalation to manufacturer