Your Official FDA Firewall.
Foreign facilities need more than a mailbox. We provide active legal representation, 15-minute emergency response, and liability coverage.
Tailored for your industry.
Compliance isn't generic. We provide specialized agent workflows designed for the unique risks of your regulated sector.
Prevent Detention & Import Alerts
Under FSMA and the Bioterrorism Act, foreign food facilities must have a responsive U.S. Agent to handle Prior Notice confirmations and emergency communications. We prevent your shipments from rotting at the port.
FSMA Compliant
21 CFR 1.227
Appoint us instantly.
No waiting for quotes. Complete our secure online form, pay the annual fee, and receive your official U.S. Agent appointment confirmation instantly. We are ready to serve.
Start appointmentWe accept the liability.
Under the FSMA Re-inspection Fee provision, the U.S. Agent is financially liable for FDA inspection costs if the foreign facility refuses to pay. Most agents hide this. We accept it fully.
Get protectedThe $99 Agent trap.
Cheap agents act as passive mailboxes. If they miss an FDA emergency call or let a detention notice sit in a spam folder, your registration is suspended and your shipment is refused.
The green light for active status.
FDA registration is not complete until your U.S. Agent affirmatively accepts the designation. We confirm instantly, ensuring your facility status flips from “Pending” to “Active” immediately.
Verify my statusWe handle the FDA call.
The FDA calls the U.S. Agent to schedule foreign facility inspections. If the agent doesn't pick up or can't coordinate with your plant manager, the FDA marks your facility as “Refused Inspection” and suspends your registration. We ensure that never happens.
Your digital certificate.
Need proof of registration for Amazon, a customs broker, or a commercial partner? Download your official Assurentry U.S. Agent Certificate instantly from your dashboard. Secure, verifiable, and always up to date.
View sample certificateRecall command center.
When a mandatory recall hits, you have hours to respond. Our U.S. Agent team acts as your emergency coordination hub, routing FDA directives to your quality team instantly, 24/7/365.
Secure emergency coverageWe watch the watchlists.
We monitor FDA Import Alerts and refusal lists daily. If a product in your category is flagged, we alert you immediately so you can adjust your documentation before shipping.
Monitor my productsAction: Refusal of Admission
Trapped on the
Red List?
An Import Alert isn't just a delay—it's a blockade. FDA has authorized customs to detain your shipments automatically. We engineer the scientific petition required to secure your Green List exemption.
Don't wait for the real audit.
FDA foreign inspections are high-stakes. Our “Mock Inspection” module helps you self-audit against 21 CFR standards before the inspector arrives. We verify your readiness gaps.
Start mock auditDUNS & FDA sync.
Mismatched address data between Dun & Bradstreet and the FDA FURLS system is the #1 cause of registration failures. We coordinate the data synchronization to ensure your unique facility identifier (UFI) is validated correctly.
Switching is painless.
Stuck with an unresponsive agent? We handle the entire transfer process. We update your FDA registration, notify the old agent, and assume responsibility seamlessly. Zero downtime.
Switch to AssurentryThe labeling gatekeeper.
Misbranding is the #1 cause of detention. Our Labeling Pre-Check service acts as your final gatekeeper, catching English formatting errors and missing warnings before your goods leave the factory.
Check my labelsWe are awake
when you are.
Compliance doesn't sleep. Our U.S. Agent Operations Center is staffed to handle communications from Asia, Europe, and the Americas in real-time. We bridge the time zone gap between you and the FDA.
24/7 Operations Center
Manage 100+ facilities.
For multinational corporations, managing dozens of registrations is a nightmare. Our Enterprise Dashboard gives you a single view of compliance status for every facility in your global network.
Explore EnterpriseMulti-Facility Overview
Global Operations
Connect to your importer.
Under FSVP, your U.S. importer must verify your compliance. We facilitate this connection, ensuring your importer has the U.S. Agent confirmation they need to clear your goods.
Why you need a Pro
The U.S. Agent is your only lifeline to the FDA. Don't cut corners.
Inspection Scheduling
FDA contacts the agent to schedule foreign inspections. Miss the call, get banned.
Detention Resolution
We coordinate with import brokers to resolve DWPE and holds quickly.
Emergency Response
Recall coordination and adverse event reporting routing in <15 mins.
Compare to Registrar Corp.
Why pay 3x more for the same legal representation? Assurentry provides a modern, digital-first experience with transparent pricing and no hidden fees.
Stop overpaying for compliance.
Switching is free and takes less than 5 minutes. We handle the FDA notification for you.
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.