Import Alerts, Refusals, and Removal from Import Alert

When a product is placed on an FDA Import Alert, it means the FDA has identified a violation, allowing them to detain shipments without physical examination (DWPE). This can halt business operations, delaying or blocking imports unless the company provides sufficient evidence to resolve the issue.

Getting Removed from an Import Alert
To be removed from an Import Alert, companies must demonstrate compliance and prove that the issue has been fully corrected.

The removal process typically requires:
✅ Investigation – Identifying the root cause of the violation.
✅ Corrective Actions – Steps taken to fix the problem.
✅ Preventive Measures – Proof that future shipments will meet FDA standards.
✅ Evidence Submission – Clean shipment records, third-party audits, or lab testing.

Our Import Alert Removal Services help businesses navigate the complex FDA process, ensuring proper documentation and guidance to expedite removal and restore smooth import operations.

Need assistance? Contact us today to get started.