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
Is a U.S. Agent the same as facility registration?
No. Facility registration identifies the establishment with FDA. A U.S. Agent is the U.S. person or company named as the communications contact on a foreign facility registration when that program requires one. They are related roles, not the same filing. Axentra can support Agent appointment and registration as scoped. For registration details, see our Facility Registration page.
Does a foreign facility need a U.S. agent to register?
Yes. For drug establishments, 21 CFR 207.69(b) requires a U.S. agent who resides or maintains a place of business in the United States, and expressly excludes a mailbox or answering service. FDA treats information given to your U.S. agent as given to you.
What is an FEI number and how do I find mine?
An FDA Establishment Identifier is the number FDA uses to identify your facility across registrations, listings and inspections. It is assigned by FDA rather than chosen by you. Axentra confirms your FEI and checks it matches the facility details on every filing.
Do foreign food facilities need a U.S. Agent?
Yes. A foreign facility’s registration must designate a U.S. Agent. The U.S. Agent may register the facility but is not required to. FDA describes the U.S. Agent as the communications link with FDA.
What does a U.S. Agent do for a foreign food facility?
A foreign facility that must register must designate a U.S. Agent. Under 21 CFR 1.227, the U.S. Agent is the communications link between FDA and the foreign facility for emergency and routine communications. FDA treats information given to the agent as given to the facility.
Is the cosmetics U.S. Agent the same legal appointment as the food-facility U.S. Agent?
No. They are separate FDA programs (FD&C Act § 607 / Cosmetics Direct vs FD&C Act § 415 / FURLS). One company can serve in both roles. One appointment does not cover both.
What does Axentra’s U.S. Agent / registration work start at?
Starting at $299 per year per facility for cosmetics, dietary supplements, and food (including pet food). That is Axentra’s fee for appointment, facility registration, and FDA communications — not an FDA fee. Listing, labels, NDI, FSVP, Form 2541 process filing, OTC, drugs, and devices are quoted separately.
Related: MoCRA cosmetics compliance, dietary supplement FDA compliance, and food facility registration. See also FDA facility registration. Read next: What foreign exporters must know about a U.S. FDA Agent (2026) A U.S. Agent is not the same as facility registration. Registration files the establishment with FDA; the Agent is the U.S. communications contact named on that registration when required. For facility registration support, see FDA Facility Registration..
Rapid
Rapid same-day response to all FDA communications
Responsive
Proactive alerts on regulatory changes and compliance needs