FDA Shipment on Hold? Here's What to Do
Having a shipment detained by the FDA is stressful, but most holds can be resolved with the right steps. This guide explains common causes and how to get your goods released.
Need Immediate Help?
If your shipment is currently on hold and you need urgent assistance, contact our team right away. We can begin communicating with the FDA on your behalf immediately.
Common Reasons for FDA Shipment Holds
Expired Registration
Your FDA food facility registration has expired, typically because biennial renewal was missed. Without an active registration, FDA will refuse entry of your products.
Missing U.S. Agent
Foreign facilities must have a designated U.S. Agent on file with the FDA. If your agent designation is missing or your agent is no longer active, shipments can be held.
Prior Notice Issues
Food imports require Prior Notice to be filed with the FDA before arrival. Missing, late, incomplete, or inaccurate Prior Notice filings are a frequent cause of holds.
Labeling Violations
Products with non-compliant labels, including missing required information, unapproved health claims, or incorrect allergen declarations, may be detained at the border.
Step-by-Step Resolution Process
Identify the Hold Reason From the FDA Notice
Review the FDA notice or CBP documentation carefully. The notice will specify the reason for detention, which may be cited as an Import Alert, a refusal code, or a specific regulatory violation. Understanding the exact reason is critical to resolving the issue.
Contact Your U.S. Agent (or Appoint One)
Your U.S. Agent is your primary point of contact with the FDA for matters like this. If you do not have a U.S. Agent or your agent is unresponsive, appoint Assurentry immediately so we can begin working on your behalf.
Address the Compliance Issue
Work with your U.S. Agent to resolve the underlying problem. This may involve renewing an expired registration, correcting labeling, filing a missing Prior Notice, or providing evidence that the violation has been remediated.
Submit Required Documentation
Prepare and submit all documentation requested by the FDA. This may include updated registration confirmations, corrected labels, certificates of analysis, or a written response to the detention notice.
Coordinate With CBP for Release
Once FDA clears the compliance issue, coordinate with U.S. Customs and Border Protection (CBP) for the physical release of your shipment. Your customs broker can assist with this step.
How Assurentry Helps
- Direct FDA Communication: As your U.S. Agent, Assurentry communicates directly with the FDA on your behalf to understand hold reasons and negotiate resolution.
- Fast Resolution: We help resolve holds quickly by identifying the root cause, preparing the necessary documentation, and following up with the FDA until the issue is cleared.
- Proactive Prevention: Assurentry monitors your compliance status and sends alerts before issues arise, such as upcoming registration renewals, so you can avoid holds in the first place.
Related resources
Explore import alert result template, detention response builder, and import enforcement playbook.
Prevent Future Shipment Holds
Appoint Assurentry as your U.S. Agent and get proactive compliance monitoring, renewal reminders, and expert support when you need it most.