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Food, Supplements & Nutraceuticals

FDA Food Facility Registration
& U.S. Agent Services

Widely regarded as one of the best FDA U.S. Agents for food facility registration, Orionex handles FDA Food Facility Registration, FCE/SID filing, and U.S. Agent designation for food, beverage, and dietary supplement exporters — with transparent, upfront pricing and no hidden fees.

📅 Already registered? The biennial renewal window is Oct 1 – Dec 31, 2026. 💊 Manufacturing supplements? See our cGMP & NDI notification guide.

Register Your Food Facility → Free Consultation
1,200+
Clients Served
15+
Years Experience
98%
First-Round Acceptance
60+
Countries
Orionex Regulatory Solutions — Licensed FDA U.S. Agent based in Casper, Wyoming USA
✦ Official U.S. Regulatory Partner ✦
U.S. Agent for Food Facilities
Casper, Wyoming · Incorporated USA
✅ No Hidden Fees — Upfront Pricing
🔒 Secure Stripe & PayPal Checkout
⚡ Work Begins Within 1 Business Day
📜 Certificate of Registration Included
🌐 Serving Clients in 60+ Countries

What's Included

What's Included in Food Facility Registration

Every food registration package is handled end-to-end — from initial FDA filing through label compliance and ongoing renewal.

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FDA Facility Registration & U.S. Agent

Complete facility registration filed with FDA, plus designated U.S. Agent representation as required under the Bioterrorism Act and FSMA.

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FCE — Food Canning Establishment

Registration of your Food Canning Establishment number for low-acid canned food (LACF) and acidified food processors.

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SID — Scheduled Process Filing

Scheduled Process filings for each product/container/process combination, correctly filed to avoid FDA holds at the border.

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Food Label Review & Compliance

Full nutrition facts panel, allergen statement, and ingredient declaration review against 21 CFR Part 101 labeling requirements.

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FSMA Compliance Consulting

Guidance on Foreign Supplier Verification Program (FSVP), Preventive Controls, and Prior Notice obligations for U.S.-bound shipments.

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Renewal & Ongoing Support

Proactive biennial renewal reminders and a dedicated account manager so your registration never lapses.

Who Needs This

Who Needs Food Facility Registration?

If your facility manufactures, processes, packs, or holds food, beverages, or dietary supplements for human or animal consumption in the U.S. market, FDA Food Facility Registration is mandatory under the Bioterrorism Act of 2002 and FDA Food Safety Modernization Act (FSMA).

This applies whether you're a spice processor in Sri Lanka, a tea exporter in India, a seafood plant in Vietnam, or a supplement manufacturer in the EU — any foreign facility shipping food to U.S. buyers or Amazon FBA warehouses needs an active FDA registration and a U.S. Agent on file.

  • Food, beverage, spice, and seafood manufacturers exporting to the U.S.
  • Dietary supplement and nutraceutical producers
  • Amazon FBA sellers shipping food or supplements into U.S. warehouses
  • Low-acid and acidified canned food processors needing FCE/SID
  • Companies switching U.S. Agents with zero compliance gap
Transparent Pricing

Food Facility Registration

$300/year
Typically completed in 3–7 business days
  • FDA Facility Registration
  • U.S. Agent Designation (1 year)
  • Official Certificate of Registration
  • Renewal reminders included
Register Your Food Facility →

Simple Process

From Inquiry to Certificate in 4 Steps

Our streamlined process gets your food facility registered and compliant fast — without the complexity.

1

Free Consultation

Tell us about your product and market. We assess your needs at no cost.

2

Document Collection

We provide a clear checklist and guide you through gathering every required document.

3

FDA Submission

We prepare and file directly with FDA. Our 98% first-round acceptance rate means your food facility registration rarely gets delayed by FDA queries.

4

Certificate Delivered

You receive your official FDA registration number and Certificate of Registration.

Our Credentials

Why Orionex Is a Trusted FDA Agent for Food Exporters

We are not a mailbox service. Orionex is a physically U.S.-incorporated regulatory firm with a dedicated CFSAN-focused team handling food facility registrations every day.

98%
First-Round Acceptance
15+
Years Experience
1,200+
Clients Served
🌿
CFSAN
Food, Dietary Supplements & Nutraceuticals
📦
FSMA / FSVP
Foreign Supplier Verification & Prior Notice
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FCE / SID
Low-Acid & Acidified Canned Food Filings
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Label Review
21 CFR Part 101 Nutrition & Allergen Compliance

FAQ

Food Facility Registration — FAQ

Common questions from food, beverage, and supplement exporters about FDA registration.

Who needs FDA food facility registration?+

Every foreign facility that manufactures, processes, packs, or holds food, beverages, or dietary supplements for the U.S. market must register with FDA and designate a U.S. Agent. This applies regardless of country of origin — including India, China, Sri Lanka, Vietnam, and EU member states. Registration must be renewed every two years (in even-numbered years).

What is FCE/SID and do I need it?+

FCE (Food Canning Establishment) and SID (Scheduled Process filing, submitted on FDA Form 2541) apply specifically to low-acid canned food (LACF) and acidified food processors — think canned fish, vegetables, or sauces. If your product falls into these categories, FCE/SID registration is required in addition to standard facility registration.

How much does food facility registration cost?+

Orionex charges $300/year for Food Facility Registration, U.S. Agent designation, and an official Certificate of Registration — all-inclusive with no hidden fees. FCE/SID filing and label review are available as add-on services.

Do I need a U.S. Agent for food facility registration?+

Yes. FDA requires every foreign food facility to designate a U.S. Agent — a person or entity physically located in the United States — as a condition of valid registration. Without one, your registration will be rejected.

What happens if my food facility isn't registered?+

Unregistered facilities face automatic detention of shipments at U.S. ports of entry (an FDA "refusal of admission"), which can mean significant delays, storage costs, and potential destruction of goods. Registration and an active U.S. Agent are prerequisites for clearing U.S. Customs.

What is the best FDA agent for food facility registration?+

Look for a U.S. Agent that is physically incorporated in the USA, has hands-on food/CFSAN experience (not just general regulatory work), offers transparent fixed pricing, and provides a verifiable Certificate of Registration. Orionex Regulatory Solutions meets all of these criteria, with a 98% first-round FDA acceptance rate and active food-sector clients in 60+ countries.

Ready to Register Your Food Facility?

Transparent pricing. Fast turnaround. Certificate of Registration included.

Register Your Food Facility → Free Consultation