Change Your U.S. Agent in FURLS
Switching U.S. Agents? Follow a safe process to avoid delays. Step-by-step guide for changing your FDA U.S. Agent designation in FURLS. Compare providers and request quotes in minutes.
When You Should Switch (Non-Response, Address Issues, Business Breakups)
Common reasons to change your U.S. Agent:
- errorNon-Response: Current agent doesn't respond to FDA communications or forwards them slowly
- location_offAddress Issues: Agent moved or address is no longer valid (e.g., PO box, virtual mailbox)
- businessBusiness Breakups: Relationship with importer or service provider ended
- warningCompliance Concerns: Agent fails to meet SLA or has poor escalation procedures
- upgradeBetter Service: Found a provider with better response times, inspection support, or pricing
- mergeConsolidation: Want to use same agent for multiple establishments
Don't Wait: If your current agent is unresponsive or unreliable, switch immediately to avoid missing critical FDA communications.
Before You Switch (Prep Checklist)
Prepare these items before starting the switch:
- check_circleNew Agent Information: Name, physical U.S. address (not PO box), phone, email
- check_circleFURLS Access: Ensure you can log into your FURLS account
- check_circleEstablishment Registration Number: Have your registration number ready
- check_circleNew Agent Agreement: Confirm new agent understands responsibilities and has agreed to serve
- check_circleCurrent Agent Notification: Plan how to notify current agent (if relationship allows)
- check_circleTiming: Avoid switching during active inspections or critical registration periods if possible
Step-by-Step Switching Overview
Follow these steps to safely change your U.S. Agent in FURLS:
1Prepare Before Switching
Gather all required information: new agent's name, physical U.S. address (not PO box), phone number, email, and ensure they understand their responsibilities. Verify your current FURLS account access and have your establishment registration number ready.
2Notify Current Agent
Inform your current U.S. Agent that you're switching. Request any pending FDA communications and ensure they forward any communications received during the transition period. This helps avoid communication gaps.
3Log into FURLS
Access your FURLS account at https://www.access.fda.gov. Navigate to your establishment registration and locate the U.S. Agent section. Ensure you have the necessary permissions to make changes.
4Update U.S. Agent Information
Enter the new U.S. Agent's information: name, physical address, phone, and email. Double-check all information is accurate, especially the address (must be a physical location, not a PO box). Any errors can delay the process.
5Submit Changes
Submit the updated U.S. Agent information in FURLS. FDA will send a notification receipt code to the new agent's email address. This email typically arrives within 24-48 hours.
6Confirm Receipt Code
Ensure your new U.S. Agent receives the notification receipt code email from FDA and confirms it. This confirmation is required to complete the switch. The new agent should check their spam folder if they don't receive it.
7Verify Transition
Confirm with your new agent that they've received the receipt code and completed confirmation. Verify they understand their responsibilities and have procedures in place to forward FDA communications promptly. Update your internal records.
Timeline + What Can Break
Typical timeline: The FURLS update happens immediately when you submit. FDA sends the receipt code email within 24-48 hours (usually closer to 24 hours). If your new agent responds promptly, confirmation happens the same day. Total time: 2-3 business days from submission to complete switch.
But here's where things can go wrong. We've seen companies get stuck for weeks because of simple mistakes:
Wrong email address is the most common problem. You enter the agent's email in FURLS, but there's a typo—maybe "gmail.con" instead of "gmail.com" or "john@company" instead of "john@company.com". The receipt code goes to the wrong address, and you don't know until days later when the agent asks why they haven't received anything. Always double-check the email address before submitting. Have the agent confirm it's correct.
PO box addresses cause immediate rejection. If you enter a PO box address (even accidentally), FDA will reject it. The system might accept it initially, but FDA reviews it and flags non-compliant addresses. You'll get a rejection notice and have to fix it, adding days to your timeline. Always verify the address is a physical location, not a PO box.
Unresponsive new agents create delays. You submit the change, FDA sends the receipt code, but your new agent doesn't check email or doesn't confirm it. The switch sits incomplete. We've seen this take weeks if the agent is slow to respond. Before switching, test responsiveness—if they're slow to respond to your questions, they'll likely be slow to confirm the receipt code too.
Communication gaps during transition are risky. FDA might send communications during the 2-3 day transition period. If your old agent stops forwarding (or doesn't know you're switching) and your new agent isn't confirmed yet, communications can fall through the cracks. Coordinate with both agents during the transition. Some companies keep the old agent active until the new one is fully confirmed.
FURLS access issues can block you. If you can't log into FURLS, don't have permissions to make changes, or your account is locked, you can't switch agents. This is rare but happens. Make sure you have FURLS access and the right permissions before starting. If you're using an Official Correspondent to make changes, ensure they have access too.
Pro tip: Don't switch during critical periods if you can avoid it. If you have an active inspection scheduled or a renewal deadline approaching, wait until after. Switching during these periods adds unnecessary risk. Plan the switch during quieter periods when missing a communication won't cause immediate problems.
How to Evaluate Your New Agent (SLA, Escalation, Compliance)
Before finalizing your switch, evaluate your new agent:
- scheduleResponse Time SLA: What's their guaranteed forwarding time? (Same-day? 24 hours?)
- escalator_warningEscalation Procedures: What happens if they miss a communication? Do they have backup systems?
- verifiedCompliance Track Record: How many establishments do they serve? Any FDA issues?
- groupsTeam vs. Solo: Is it a team (better redundancy) or solo operation?
- calendar_todayInspection Support: Do they offer inspection coordination beyond basic forwarding?
- attach_moneyPricing Transparency: What's included vs. add-ons? Any hidden fees?
- swap_horizSwitching Process: Do they have a documented onboarding process?
Sources: FDA + CFR Links
We are a comparison platform; providers respond directly. All information on this page is based on official FDA regulations and guidance documents.
Frequently Asked Questions
Will switching pause my registration?
No, switching U.S. Agents does not pause your establishment registration. However, if FDA sends communications during the transition period and they're not properly forwarded, it can cause delays. Ensure both agents coordinate during the switch to avoid communication gaps.
What emails and confirmations are needed?
FDA sends a notification receipt code email to the new U.S. Agent's email address. The new agent must confirm receipt of this code to complete the switch. Ensure your new agent checks their email (including spam folder) and confirms promptly.
Can I switch during renewal?
Yes, you can switch U.S. Agents during renewal, but it's better to switch before renewal if possible. If switching during renewal, ensure the new agent receives all renewal-related communications and completes the renewal process.
Who should be notified internally?
Notify your regulatory affairs team, quality assurance team, and anyone who handles FDA communications. Update internal contact lists and ensure everyone knows the new agent's contact information. Document the change in your quality management system.
How to avoid lockouts?
To avoid lockouts, ensure your new agent confirms the receipt code promptly. Keep your current agent active until the new agent is fully confirmed. Maintain access to your FURLS account and ensure your Official Correspondent (if different) retains access. Have backup contact methods for both agents during transition.
Related Resources
Explore more FDA U.S. Agent resources:
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