U.S. FDA Agent Services for Foreign Manufacturers
Official Representation for Foreign Manufacturers
This page is for foreign facilities that need to appoint Axentra as their U.S. FDA Agent, with an annual fee covering Agent appointment and FDA communications, plus facility registration support when needed. For a deeper educational overview, see our Related guide for exporters.
Foreign food facilities that register under 21 CFR 1.225 designate a U.S. Agent under 21 CFR 1.227. Foreign drug establishments designate a U.S. Agent under 21 CFR 207.40. Cosmetic U.S. Agent work is scoped when the facility needs one.
The FDA does not view the U.S. Agent as a formality; they view us as you. Under the law, providing information to your U.S. Agent is legally equivalent to providing it to your foreign facility.
The FDA expects Axentra to:
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Be Reachable 24/7: Answer the phone during U.S. business hours (Eastern Time) for emergency communications.
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Facilitate Inspections: Coordinate travel, scheduling, and logistics for FDA investigators visiting your foreign plant.
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Respond Instantly: FDA deadlines are tight. A 24-hour delay in responding to a detention notice can cost you thousands in storage fees.
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Maintain Data Accuracy: Ensure your DUNS number, facility address, and product listings are 100% accurate to prevent registration cancellation.
We Serve :
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Pharmaceutical Manufacturers (API, FDF, OTC, Clinical Trial Materials)
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Medical Device
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Dietary Supplement Manufacturers
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Cosmetic Manufacturers & Brand Owners (Under MoCRA)
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Food & Beverage Facilities
The Reality: If your manufacturing site is outside the United States, you cannot register with the FDA or ship a single unit to the U.S. without a registered U.S. Agent.
Risk of a "Passive Agent"
Many foreign companies choose the cheapest U.S. Agent they can find. This is a critical business error. A non-responsive agent is treated by the FDA as a compliance risk, not a clerical issue.
Consequences of a "Ghost" Agent:
1
FDA Emails - Unanswered
Resulting in immediate facility registration cancellation
2
Import Detentions
Shipments held at U.S. Customs because the agent did not confirm "Prior Notice."
3
Missed Inspection Notices
If the FDA tries to schedule an inspection and your agent misses the email, your facility goes on Import Alert (Red List).
4
Costly Delays
Communication lags that result in weeks of lost sales.
The Axentra Difference
We are not a "Name-on-Paper" Agent. We operate as your active U.S. Compliance Office. We protect your market access
Our Service Guarantee:
Active Liability Shield
We review FDA communications before forwarding them to you, adding our expert analysis on how to respond.
Zero Outsourcing
We do not farm out this responsibility. Your U.S. Agent is Axentra Global, based in New Mexico, USA
Compliance Dashboard
We maintain clean, traceable documentation of all FDA interactions.
No Surprises
You will never miss an FDA notice, inspection request, or registration renewal deadline.
U.S. FDA Agent — Frequently Asked Questions
Do foreign manufacturers need an FDA U.S. Agent?
If your foreign facility manufactures, processes, packs, or holds food (including dietary supplements) for U.S. consumption, you should designate a U.S. Agent as part of FDA food facility registration. The agent is FDA’s communications link in the United States and must reside in or maintain a place of business in the U.S.—not a mailbox or answering service alone. Separate programs (devices, drugs, cosmetics) have their own agent rules; confirm the category that applies to your products. Axentra provides U.S. Agent services starting at $299/year for cosmetics, supplements, and food where that offering applies.
What is the difference between an FDA U.S. Agent and FDA facility registration?
Facility registration is the facility’s filing with FDA (identity, activities, product categories, and required contacts). A U.S. Agent is the U.S.-based person or entity named in that registration so FDA can reach the foreign facility for routine and emergency communications. You should complete registration with accurate agent details; FDA does not confirm a foreign food facility registration until the designated agent confirms they agreed to serve. Registration assignment is not product approval.
Who can serve as an FDA U.S. Agent for a foreign food facility?
Under 21 CFR 1.227, a U.S. Agent is a person who resides in or maintains a place of business in the United States and is designated by the foreign facility for registration purposes. The agent may not be only a mailbox, answering machine, or service where no individual is physically present. One person is designated as the U.S. Agent for food facility registration; that does not prevent other commercial agents (e.g., brokers) for other business purposes.
What does an FDA U.S. Agent actually do?
For foreign food facilities, the U.S. Agent acts as the communications link between FDA and the facility for routine and emergency contacts. FDA treats information or documents provided to the agent as provided to the facility, and may treat agent representations as those of the facility. The agent is not automatically your importer of record, customs broker, or FSVP importer unless you separately arrange that role.
Can I change my FDA U.S. Agent?
Yes. Food facility registration information - including U.S. Agent name, address, phone, and email - should be updated within 60 calendar days of a change (21 CFR 1.234). After you update agent information, FDA verifies that the newly named person agreed to serve before confirming the update. Plan the handoff so confirmation is not left hanging during busy renewal windows.
Why hasn’t FDA confirmed my foreign facility registration after I submitted it?
For foreign food facilities, FDA will not confirm registration or issue a registration number until the person named as U.S. Agent confirms they agreed to serve (21 CFR 1.231). FDA also verifies the facility’s unique facility identifier (UFI; currently DUNS). If agent confirmation or UFI verification fails, fix those fields and resubmit rather than assuming the portal “lost the filing.
Rapid
Rapid same-day response to all FDA communications
Responsive
Proactive alerts on regulatory changes and compliance needs