Get Off the Red List.
Complete Import Alert petition support. We analyze your violation, coordinate lab testing, and prepare the evidence package to restore your Green List status.
Detention Without
Physical Examination.
If you are on an Import Alert (the “Red List”), FDA does not need to inspect your shipment to refuse it. The burden of proof shifts to you. Every shipment is detained until you prove it is clean.
Your shipments are automatically detained. FDA does not need to inspect them to refuse entry. The burden of proof is 100% on you.
The Petition Roadmap.
Getting off the list requires a formal petition to FDA Division of Import Operations (DIO). We manage the entire 5-step process.
Exemption Status:
Green List.
For country-wide alerts (like Enoki Mushrooms from Korea), you don't need to fix the whole country. You just need to get your firm on the Green List of exempt manufacturers.
Find the Source.
FDA won't accept “we cleaned the factory.” You must prove you found the root cause of the contamination and implemented permanent corrective actions (CAPA).
5 Clean Shipments.
Consecutive.
FDA typically requires evidence from at least 5 consecutive commercial shipments to prove your problem is fixed. We coordinate the sampling and private lab analysis for every single one.
Direct Lab Uplink.
Don't chase PDFs. We connect directly with FDA-accredited private labs. Results are pushed straight into your petition package, ensuring Chain of Custody compliance.
Cost of Delay
Demurrage kills
margins.
Every day your container sits at the port waiting for lab results or FDA review, you pay storage fees. Our automated petition process cuts weeks off the timeline.
Stop it before the border.
Our Pre-Shipment Scan tool checks your supplier against the Red List before you load the container. Don't pay shipping on goods that will be refused.
Watch your Rivals.
Get notified when a competitor is placed on an Import Alert. While they are stuck in detention, seize the opportunity to capture market share.
The Perfect
Petition Package.
A rejected petition resets the clock. We assemble a 100-page evidence package including root cause analysis, lab reports, and corrective action plans (CAPA) formatted exactly how FDA DIO reviewers want to see it.
The Removal Track Record
We get companies off the list faster than anyone else.
Don't get caught by surprise
Import Alerts change daily. We monitor the list so you don't ship into a detention.
Daily Scanning
We scan FDA's database every 24 hours for your manufacturers.
Country Alerts
Track country-wide alerts (e.g. Enoki Mushrooms from Korea).
Lab Coordination
If detained, we coordinate FDA-approved private lab testing.
Platform vs. Law Firms.
Law firms charge by the hour. We charge a flat fee for the petition package. Same result, predictable cost.
Stop the bleeding.
Every day on the Red List costs you money. Start your removal petition now.
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.