Avoid FDA Detention.
Secure Your U.S. Agent in 12 Minutes.
FSMA Section 305 demands a physical U.S. presence. We guarantee instant FDA FURLS acceptance for a flat $399/year—shielding your food shipments from Import Alert 99-41.
Import Alert 99-41 is triggered instantly.
If your food facility registration lapses, or if your U.S. Agent fails to respond to an FDA inquiry, your facility is automatically placed on FDA Import Alert 99-41. Every shipment you send to the U.S. will be halted at the port. Demurrage fees start immediately, ruining perishables and profit margins.
Entry Refused
HOLD: IMPORT ALERT 99-41
The "Hidden Fee" Trap.
Legacy regulatory firms lure you in with a base fee, then charge you for every standard compliance task. We believe in one flat rate.
"The U.S. agent must reside or maintain a place of business in the United States and be physically present... The U.S. agent may not just use a mailbox, answering machine or service..."
P.O. Box / Virtual
Assurentry HQ
The Physical Presence Mandate.
You cannot use a virtual office, a P.O. Box, or an answering machine. The law is absolute.
- Geographic Reality: Must reside in the US.
- 24/7 Availability: FDA emergency contact.
- Legal Proxy: Representations are legally binding.
The Biennial Renewal Trap.
Unlike medical devices, food facility registrations do not automatically roll over. Under the Food Safety Modernization Act (FSMA), you must affirmatively renew your registration every even-numbered year. Assurentry automatically files your renewal paperwork for free. You will never wake up on January 1st to a cancelled registration.
Biennial Renewal
Required every even-numbered year.
Auto-Renewal
Our system automatically initiates the renewal, verifying DUNS matches and confirming U.S. Agent designation free of charge.
Translating FDA Legalese.
When the FDA sends a notice, it is written in dense regulatory code. Misinterpreting a Notice of Action can lead to facility suspension. We translate the risk into an actionable plan.
Dear Sir/Madam: The Food and Drug Administration (FDA) has reviewed your facility's registration pursuant to section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. § 350d] and the implementing regulations in 21 CFR Part 1, Subpart H.
Our records indicate a discrepancy between the Unique Facility Identifier (UFI) recognized by FDA and the entity name registered in FURLS. Pursuant to 21 CFR 1.231(a)(3), you are required to submit the DUNS number.
Failure to update this information within the prescribed timeframe may result in suspension of registration under 21 U.S.C. 350d(b)(1).
You must log into the FDA Industry Systems (FIS) portal and navigate to the FDA Unified Registration and Listing Systems (FURLS) Food Facility Registration Module (FFRM) to update the required fields.
Build Importer Confidence (FSVP).
U.S. importers are terrified of the Foreign Supplier Verification Program (FSVP). Assurentry certification signals that your compliance is bulletproof, closing deals faster.
Foreign supplier
Targeting US MarketU.S. importer
Approved to buy"U.S. Importers will reject foreign suppliers without verified FDA compliance due to their own FSVP liability. Assurentry acts as the bridge of trust."
Mastering the DUNS Disconnect.
The exact spelling, punctuation, and address format in the FDA database must cryptographically match the Dun & Bradstreet database. If it doesn't, your registration fails. We handle this alignment for free.
Dun & Bradstreet
FDA FURLS DB
The Notice of Inspection (NOI) Interceptor.
When the FDA decides to inspect your foreign facility, they call your U.S. Agent first to schedule it. A missed call flags you as non-cooperative. We intercept, negotiate dates, and prep your QA team.
U.S. Agent
FDA"We intend to inspect your client's facility in 5 days. Are they ready?"
Without an agent answering, or if the agent misses the call, the FDA flags the facility for non-cooperation immediately.
Triage
Prior Notice Velocity & ACE Integration.
Shipments require a Prior Notice filing before hitting the U.S. Port. If CBP's Automated Commercial Environment (ACE) detects an invalid U.S. Agent, your Prior Notice is rejected. We guarantee ACE validation.
Strict Deadlines
ACE / ITDS Velocity
Automated SystemEvery Prior Notice filing requires the foreign manufacturer's FDA Registration Number and active U.S. Agent details. If this data is missing or invalid, the CBP automated commercial environment (ACE) rejects the entry instantly.
FDA Emergencies Wait For No One.
The FDA expects immediate response times. Assurentry provides 24/7/365 coverage for over 160+ countries. When the FDA calls, we answer.
FDA emergencies wait for no one.
The FDA operates on U.S. Eastern Standard Time (EST). If an emergency communication is sent at 4:00 PM EST, it might be 4:00 AM in your country. The FDA expects the U.S. Agent to answer immediately.
24/7/365 Coverage
We support over 160+ countries. When the FDA calls, we answer on the first ring.
The Secure Audit Vault.
Every interaction, designation, and certificate is cryptographically stored and instantly accessible for your buyers or inspectors.
Compliance Document Vault
Every interaction, designation, and certificate is cryptographically stored and instantly accessible for your buyers or inspectors.
U.S. Agent Designation Cert
FDA Renewal Confirmation
DUNS Verification Record
Radical Transparency.
We answer the hard questions our competitors won't.
One flat fee. Complete peace of mind.
Stop paying hourly retainers for mandatory compliance.
U.S. Agent Designation
The complete compliance representation package.
Secure SSL Checkout. No setup fees. Cancel anytime.
What's Included:
- Official 21 CFR 1.227 Designation
- Instant FURLS Acceptance
- Digital Compliance Certificate
- Free Biennial Renewal Filing
- Free DUNS Validation Support
- Unlimited FDA Comm Handling
- Prior Notice Integration
Certificate of Registration
Facility
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.