Foreign food and drug establishments designate a U.S. Agent as part of FDA registration. Cosmetic Agent work is scoped when the facility needs one. Axentra acts as your active U.S. Agent — we receive FDA inspection notices, warning letters, and MoCRA correspondence on your behalf, review them before forwarding, and keep your registration and DUNS details accurate so you never lose market access. Transparent annual pricing, no outsourcing, based in New Mexico.
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.
Pharmaceutical Manufacturers (API, FDF, OTC, Clinical Trial Materials)
Medical Device
Dietary Supplement Manufacturers
Cosmetic Manufacturers & Brand Owners (Under MoCRA)
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.
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:
Be Reachable 24/7: Answer the phone during U.S. business hours (Eastern Time) for emergency communications.
Facilitate Inspections: Coordinate travel, scheduling, and logistics for FDA investigators visiting your foreign plant.
Respond Instantly: FDA deadlines are tight. A 24-hour delay in responding to a detention notice can cost you thousands in storage fees.
Maintain Data Accuracy: Ensure your DUNS number, facility address, and product listings are 100% accurate to prevent registration cancellation.
1
Resulting in immediate facility registration cancellation
2
Shipments held at U.S. Customs because the agent did not confirm "Prior Notice."
3
If the FDA tries to schedule an inspection and your agent misses the email, your facility goes on Import Alert (Red List).
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Communication lags that result in weeks of lost sales.
We are not a "Name-on-Paper" Agent. We operate as your active U.S. Compliance Office. We protect your market access
We review FDA communications before forwarding them to you, adding our expert analysis on how to respond.
We do not farm out this responsibility. Your U.S. Agent is Axentra Global, based in New Mexico, USA
We maintain clean, traceable documentation of all FDA interactions.
You will never miss an FDA notice, inspection request, or registration renewal deadline.
It depends on what you make. Drug establishments register through FURLS Drug Registration and Listing; cosmetic facilities register through Cosmetics Direct under MoCRA; food facilities register under 21 CFR Part 1 Subpart H. A facility making more than one product class may need more than one registration.
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.
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.
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.
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.
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.
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.
Rapid
Rapid same-day response to all FDA communications
Responsive
Proactive alerts on regulatory changes and compliance needs