FDA · FOOD FACILITY REGISTRATION
We manage the entire registration for you — in plain English, fast, and done right the first time.
This applies to you if you are:
Any facility that manufactures, processes, packs, or holds food for human or animal consumption in the United States must register with the FDA under FSMA §415 — whether the facility is located inside the U.S. or abroad. If you are a foreign manufacturer, packer, or exporter shipping food products to U.S. buyers, this requirement applies to you.
Registration is what allows your facility to legally introduce food into U.S. commerce. It is not an approval of your product and it is not a quality endorsement — it is the FDA's way of knowing who you are, what you make, and where, so your goods can clear and reach your buyer without avoidable holds.
If your facility sits outside the United States, a U.S. Agent is also required — a role we handle for you (details further down).
This is the single most common misunderstanding we correct for our clients. The FDA does not issue a registration certificate. No agency document, seal, or “FDA-approved” certificate exists for food facility registration — and anyone promising you one is misrepresenting how the FDA works.
What you actually receive when registration is complete is two things: a confirmation that your facility is registered in the FDA’s system, and your facility’s FEI number (FDA Establishment Identifier) — the FDA’s key identifier for your facility. That FEI is what proves your registration is active.
To give you and your U.S. buyers something tangible, we provide a private confirmation document summarizing the registration we managed on your behalf, including your FEI. It is issued by us, clearly as a private service record — never as an FDA document — so your buyer has paperwork in hand while staying fully accurate about what the FDA does and does not provide.
We take the entire process off your plate. You give us the basic information about your facility and products; we handle the FDA paperwork, the account setup, the identifiers, and the U.S. Agent requirement — and we keep you informed in your language at every step — including FDA food label review when your product needs it.
Choose the term that fits your plans:
Prices are one-time payments for the term selected and cover our management service. If your specific product requires additional FDA steps, we'll tell you up front — never a surprise.
Complete a short form with your facility and product details. We tell you exactly what's needed — no FDA jargon, no guesswork.
We set up your FDA account, file your facility registration, and act as your U.S. Agent. We obtain your FEI and confirm every identifier your registration requires.
You get confirmation that your facility is registered, your FEI number, and our private service record summarizing the work — ready to share with your U.S. buyers. Typical turnaround is just a few business days.
The FDA requires every facility located outside the United States to designate a U.S. Agent — a contact based in the U.S. who acts as the communication link between your facility and the FDA. Without a valid U.S. Agent, your registration cannot stand.
We act as your U.S. Agent. That means a real U.S.-based point of contact for the FDA, included in our service, so you never have to find, vet, or manage a separate agent yourself.
One important distinction: a U.S. Agent is not the same as a “Responsible Person” — a separate role used in other FDA programs. For food facility registration, the U.S. Agent is what the FDA requires, and that’s what we provide.
A food facility registration is not permanent. Under FSMA, every food facility must renew its registration every two years, during the renewal window that runs from October 1 to December 31 of each even-numbered year. Miss that window, and your registration expires — which can stop your shipments at the U.S. border until it’s restored.
We track your renewal cycle and manage it proactively, so your registration stays active without you having to watch the calendar. When the renewal window opens, we handle the filing — you simply keep selling.
Discover what's required to register your facility with the FDA. Get a clear, practical guide — leave your details and take the first step toward exporting to the United States.
Get your food facility registered the right way — managed end to end, in plain English, with your U.S. Agent included.
REGISTRO-FDA.US is a private company and is not affiliated with, endorsed by, or connected to the U.S. Food and Drug Administration (FDA). We provide paid consulting and filing services to help businesses meet FDA requirements. The FDA does not issue registration certificates; any confirmation document we provide is a private service record.
