Import Alert Removal.
Stuck on the Red List? We manage the entire removal process: Root Cause Analysis, 5 consecutive clean shipments, and the final FDA Petition.
Am I on the Red List?
FDA Import Alerts allow “Detention Without Physical Examination” (DWPE). If your company or product is listed, your shipments will be automatically held at the port.
Petition to Removal.
Getting off the list is a rigorous legal process. You must prove compliance through 5 consecutive clean shipments and submit a formal petition to the Division of Import Operations.
Start The ProcessRoot Cause Analysis.
You cannot just re-ship. FDA requires a detailed Root Cause Analysis (RCA) showing exactly why the violation occurred and what Corrective Actions (CAPA) you implemented.
GREEN LIST
Exempt from DWPE
The Green List.
Some alerts (like 99-33 for Milk) have a “Green List” of exempted firms. We help you petition for Green List status so your goods sail through customs without testing.
Stop the Bleeding.
Storage fees (demurrage) at the port can cost hundreds per day. Every day you wait to respond to an FDA detention is money lost. We act in under 24 hours.
Evidence Package.
We assemble the complete legal package: 766 forms, private lab results, analytical packets, affidavits, and the formal petition letter to the Division of Import Operations (DIO).
Private Lab Coordination.
FDA laboratories are backed up. We coordinate with ISO 17025 accredited private labs to test your detained product and generate the analytical packets FDA requires for release.
Find a LabFD-766 Authorization.
Labeling error? We file Form FD-766 to request permission to recondition or relabel the goods at the port, saving them from destruction.
Decipher the Notice.
“Detained” vs. “Refused” vs. “Hold”. The language matters. We translate FDA's Notice of Action into a clear action plan within minutes.
The shipment described below is currently being detained.
Reason: The article appears to be violative of Section 801(a)(3).
Refusal of Admission will occur if response is not received within 10 days.
Salmonella Protocol.
Import Alert 99-19 is the most common food detention. It requires specific sampling methods (30-60 subsamples) and PCR testing. We manage the entire protocol.
Medical Device Holds.
Devices are often held for lack of 510(k), registration, or UDI. We verify your FURLS status and provide the “Affidavit of Compliance” needed for release.
Risk of Refusal.
If you fail to respond or your petition is denied, the goods are “Refused.” You have 90 days to export or destroy them under CBP supervision. Total loss.
Expedited Review.
Our digital petitions are structured for DIO reviewers, reducing back-and-forth. We aim for removal in 45 days vs. the industry average of 3-6 months.
Predictive Compliance.
We analyze your supplier history and product category against FDA's PREDICT algorithm to warn you of high-risk shipments BEFORE they leave the factory.
Every Port of Entry.
Whether your goods are stuck in Long Beach, Newark, or Savannah, our platform covers all 300+ US ports of entry. We handle the local FDA import office digitally.
Platform vs. Consultants.
Don't pay hourly fees for a process we've automated.
Don't stay detained.
Every day on the Red List costs you market share. Start your removal petition now.
Full Detention Defense
Everything you need to get your shipment released and your name cleared.
Private Lab Coordination
We coordinate testing with FDA-approved labs.
Testimony Drafting
Legal arguments to prove compliance.
Shipment Monitoring
Tracking the 5 consecutive shipments required for removal.
Frequently Asked Questions
Common questions about this regulatory requirement.
Secure Your Supply Chain.
Don't let a clerical error stop your shipment at the border. Join 2,800+ food companies who trust Assurentry for automated compliance.