FDA U.S. Agent Address Requirements (No PO Box)
FDA U.S. Agent address must meet strict requirements per 21 CFR 807.40. Use this checklist to avoid registration delays. PO boxes are not acceptable. Compare compliant providers and get quotes.
Why Address Compliance Matters
Under 21 CFR 807.40, your U.S. Agent must have a physical place of business in the United States. This isn't just a formality—it's a critical requirement that exists for real operational reasons.
FDA sends important regulatory communications via postal mail. We're not just talking about routine renewal reminders (though those matter too). Inspection notices, recall notifications, and emergency alerts all arrive at your U.S. Agent's address. If that address is a PO box or virtual mailbox that isn't checked regularly, you'll miss critical communications.
Here's a real scenario we've seen: A company used a PO box address for their U.S. Agent. FDA sent an inspection notice to that PO box. The agent checked the PO box once a week. By the time they saw the inspection notice, the inspection date had passed. FDA considered the company non-compliant for missing the inspection, which created compliance issues and potential penalties. This could have been avoided with a proper physical address.
Registration compliance depends on this. When FDA reviews your establishment registration, they verify the U.S. Agent address. If they find a PO box, they'll reject your registration. You'll have to fix it and resubmit, which adds days or weeks to your timeline. We've seen companies get all the way through FURLS registration only to have FDA reject it at the final review stage because the agent address was non-compliant.
The regulation is explicit: 21 CFR 807.40(d) states: "The U.S. Agent cannot be a post office box." There's no wiggle room here. PO boxes are prohibited, period. Some companies try to use "Suite" or "Unit" numbers that are actually PO boxes in disguise, but FDA catches these during review. Don't risk it—use a real physical address.
Compliance risk extends beyond registration. If FDA sends urgent communications (like recall notices) and your agent doesn't receive them promptly because of address issues, you could face serious compliance problems. Missing a recall notification can result in FDA enforcement actions, product seizures, or even criminal penalties in extreme cases. The address requirement exists to prevent these scenarios.
Acceptable vs Not Acceptable (Table Examples)
Understanding what addresses are acceptable helps you verify provider compliance:
| Address Type | Status | Example | Notes |
|---|---|---|---|
| Physical Business Address | ✓ Acceptable | 123 Main Street, Suite 200, New York, NY 10001 | Real office location with staff available during business hours |
| Law Firm Office | ✓ Acceptable | 456 Regulatory Ave, Washington, DC 20001 | Physical law office that handles U.S. Agent services |
| Shared Office / Co-working | ✓ Acceptable* | 789 Business Center, Los Angeles, CA 90001 | Acceptable if reliable mail forwarding procedures are in place |
| Post Office Box | ✗ Not Acceptable | P.O. Box 123, Miami, FL 33101 | Explicitly prohibited by 21 CFR 807.40(d) |
| Virtual Mailbox Service | ✗ Not Acceptable | Virtual Mailbox #456, Anywhere, USA | Most virtual mailboxes use PO boxes or don't meet physical address requirement |
| Residential Address | ✓ Acceptable* | 321 Home Street, Austin, TX 78701 | Acceptable if it's a real physical address and someone is available during business hours |
| Mail Forwarding Service | ✗ Usually Not Acceptable | Mail Forward Co., Forwarding Address | Most mail forwarding services use PO boxes. Verify they use a real physical address. |
* Acceptable with conditions: Must have reliable mail forwarding and availability during business hours.
Red Flags (Virtual Mailboxes, Unstaffed Locations, Slow Response)
Watch out for these red flags when evaluating U.S. Agent addresses:
- errorVirtual Mailbox Services: Many use PO boxes or don't have physical staff available
- errorUnstaffed Locations: Addresses where no one is available during business hours
- errorSlow Response Times: Providers who don't check mail regularly or forward slowly
- errorFrequent Address Changes: Providers who move frequently indicate instability
- errorPO Box Disguised: Some services use "Suite" or "Unit" numbers but are actually PO boxes
- errorNo Verification: Providers who won't verify their address setup or mail handling procedures
How to Spot: Ask providers directly about their address setup. Request verification that it's a physical location (not a PO box) and ask about their mail handling procedures.
How to Verify Your Provider's Address Setup
Before selecting a U.S. Agent, verify their address meets FDA requirements:
- check_circleAsk Directly: "Is your address a physical location or a PO box?" Get a clear answer.
- check_circleVerify Address Format: Check if the address looks like a real street address (not "P.O. Box" or "PMB")
- check_circleGoogle Maps Check: Use Google Maps to verify the address exists as a physical location
- check_circleAsk About Mail Handling: "How often do you check mail? What's your forwarding procedure?"
- check_circleRequest References: Ask for other establishments they serve who can verify their reliability
- check_circleCheck Business Registration: Verify the business is registered at that address (if applicable)
- check_circleTest Communication: Send a test communication to verify they receive and forward promptly
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
Can a U.S. Agent use a PO box?
No. Per 21 CFR 807.40(d), a U.S. Agent cannot use a post office box. The regulation explicitly states "The U.S. Agent cannot be a post office box." The agent must have a physical U.S. address where someone is available during business hours to receive FDA communications.
Can it be a shared office?
Yes, a shared office or co-working space is acceptable, provided it's a physical address (not a PO box) and someone is available during business hours to receive FDA communications. However, ensure the provider has reliable mail forwarding procedures in place.
Can it be a lawyer's office?
Yes, a lawyer's office can serve as the U.S. Agent address, provided it meets the requirements: physical U.S. address (not PO box) and availability during business hours. Many law firms offer U.S. Agent services as part of their regulatory practice.
What about mail forwarding?
Mail forwarding services that use a physical address (not a PO box) may be acceptable, but you must ensure the service reliably forwards FDA communications promptly. However, many mail forwarding services use virtual mailboxes or PO boxes, which are not acceptable. Verify the service uses a real physical address.
What if my agent moves?
If your U.S. Agent moves, you must immediately update their address in FURLS. Failure to maintain an accurate address can cause FDA communications to be lost or delayed. If your agent moves frequently, consider switching to a more stable provider.
How does FDA contact the agent?
FDA contacts the U.S. Agent via mail sent to the physical address on file in FURLS. FDA may also call the phone number on file for urgent matters. The agent must be available at the address during business hours to receive these communications and forward them to you promptly.
Related Resources
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