FDA DWPE Response Checklist: What to Do in the First 24 Hours

Quick answer

If your shipment is placed under detention without physical examination (DWPE), your first objective is to identify the exact detention basis, assemble evidence, and respond through the right channel before storage costs escalate.

DWPE first-24-hour checklist

• Obtain the FDA/CBP notice and refusal code from your broker.
• Match the detention reason to registration, labeling, prior notice, or alert history.
• Validate facility registration and U.S. Agent status for the shipment origin.
• Pull COAs, production records, and shipping documents into one response folder.

Evidence package structure

Build one index with claim-to-evidence mapping so reviewers can verify each corrective point quickly. Include document version/date and a single owner per evidence item.

Escalation path and timelines

If evidence is incomplete, escalate internally within hours, not days. Use a detention playbook with owner SLAs and daily checkpoint updates until disposition.

Prevention controls

Add pre-shipment checks for registration validity, prior notice accuracy, and import-alert exposure before cargo moves.

Related resources: shipment-on-hold guide, detention response builder, import enforcement playbook.