FDA Consulting Services in Fremantle, Australia
Trusted by 1,000+ companies across 135+ countries, with 15+ years of FDA regulatory experience. As a U.S.-based firm, we help Fremantle seafood, food, and agribusiness exporters register with the FDA and reach the U.S. market — and we can serve as your U.S. Agent.
FDA Services for Fremantle Exporters
Food & Seafood
Rock lobster, prawns, abalone & scallops. Foreign food facility registration, Seafood HACCP, allergen review, U.S. Agent & FSVP.
Supplements & Cosmetics
Marine & natural products. MoCRA cosmetic registration and Part 111 supplement registration, with a U.S. Agent.
Drugs & Pharma
Pharmaceutical and OTC exporters. Drug establishment registration, listing, NDC labeler codes, and a U.S. Agent.
Medical Devices
Device and diagnostic exporters. Foreign device registration, listing, premarket pathway, and a U.S. Agent.
Finfish, Crustacean, or Mollusc?
All seafood registers and follows a HACCP plan — but the kind of seafood decides which extra rules apply. Crustaceans and bivalves each bring their own requirements.
| Seafood | FDA framework | Key requirement |
|---|---|---|
| Finfish | Seafood HACCP | Histamine & parasite controls |
| Crustaceans (rock lobster, prawns) | Seafood HACCP | Crustacean allergen; cold chain |
| Bivalve molluscs (scallops, mussels) | NSSP + Seafood HACCP | Harvest classification; country agreement |
| Abalone | Seafood HACCP | Mollusc allergen; processing & cold chain |
A missing HACCP plan or an undeclared shellfish allergen is a classic reason seafood gets held. We confirm your facility registration, build the Seafood HACCP plan, handle harvest-area and country-agreement questions for bivalves, declare crustacean and molluscan shellfish allergens, and document the cold chain — so your seafood clears U.S. review.
A Seafood Gateway, Cleared for the U.S.
Fremantle — Western Australia's historic port at the mouth of the Swan River, home to its fishing-boat harbour — is the gateway for the state's premium wild-caught seafood: western rock lobster, Australia's most valuable single-species fishery, along with prawns, scallops, and abalone.
For the U.S. market, the seafood type sets the path. Fish and crustaceans like rock lobster follow Seafood HACCP, with crustacean declared as a major allergen and the cold chain documented; bivalve molluscs like scallops add the National Shellfish Sanitation Program, harvest-area classification, and the FDA shellfish agreement. The facility registers and appoints a U.S. Agent, while the importer runs FSVP and Prior Notice. WA grain and agriculture also export, and wine from Margaret River falls under the Alcohol and Tobacco Tax and Trade Bureau — not the FDA. We're a U.S.-based firm guiding Fremantle exporters across every FDA-regulated category.
A Step-by-Step Checklist
FDA Registration for Every Product Type
Whatever you export from Fremantle, we handle the full FDA pathway by category: FDA food facility registration, FDA drug establishment registration, medical device registration, and MoCRA cosmetic registration — with U.S. Agent services for each. Tell us your product, and we'll map the exact steps.
FDA Compliance for Your Fremantle Exports
Tell us your facility and products — rock lobster, prawns, abalone, scallops, finfish, grain, supplements, or cosmetics — and we'll confirm exactly which FDA requirements apply, build your Seafood HACCP plan, address shellfish-program requirements, review labeling, appoint your U.S. Agent, and coordinate FSVP and Prior Notice with your importer. Email info@fdaregistrationassistance.com or call +1 (928) 275-8333.
Frequently Asked Questions — FDA Consulting in Fremantle, Australia
Do companies in Fremantle need FDA registration to sell in the U.S.?
Many do. If your Western Australia business produces, processes, packs, or holds FDA-regulated seafood, food, supplements, cosmetics, drugs, or devices intended for the U.S. market, the foreign facility generally must register with the FDA. What you file depends on the product.
What makes Fremantle distinctive for FDA compliance?
Fremantle is the gateway for Western Australia's premium wild-caught seafood — rock lobster, prawns, abalone, and scallops. So the FDA work here often centers on seafood, where Seafood HACCP and, for bivalve shellfish, the molluscan shellfish program drive compliance.
Is a U.S. Agent required for an Australian exporter?
Yes. Every foreign facility that registers with the FDA must appoint a U.S. Agent located in the United States to serve as the FDA's contact. FDA Registration Assistance can act as your U.S. Agent.
How does a foreign seafood facility register with the FDA?
The facility submits a food facility registration, obtains a DUNS Number as its Unique Facility Identifier, and appoints a U.S. Agent. Seafood processors also need a HACCP plan. We prepare and submit the registration and help build the plan.
What is Seafood HACCP?
Seafood HACCP, under 21 CFR Part 123, requires seafood processors to analyze hazards and control them with a written plan. It covers fish and crustaceans like rock lobster and prawns. We help you build and document the plan so your seafood clears U.S. review.
How is Western rock lobster handled?
Rock lobster is a crustacean, so it follows Seafood HACCP, and crustacean shellfish is a major U.S. allergen that must be declared. Live and whole-product handling and cold chain matter, and we build those controls into your plan and labels.
Can we export live seafood to the U.S.?
Often, yes, but live and whole seafood still need a registered facility, a HACCP plan covering the hazards, correct labeling, and temperature control through transport. We map the requirements for live and whole-product exports.
Is crustacean shellfish a major allergen?
Yes. Crustacean shellfish — including lobster, prawns, and crab — is one of the major U.S. allergens and must be declared clearly on the label. We make sure your seafood labels carry the right allergen statement.
How are bivalve molluscs — scallops, mussels — treated?
Bivalve molluscan shellfish fall under the FDA's National Shellfish Sanitation Program in addition to Seafood HACCP. That adds harvest-area controls and a requirement that the exporting country have a shellfish-safety agreement with the FDA. We map what applies to your shellfish.
What is the National Shellfish Sanitation Program?
The NSSP is the FDA's framework for the safety of molluscan shellfish — covering where bivalves are harvested, how harvest waters are classified, and how product is tracked from water to market. We help you understand how it affects your scallop or mussel exports.
Does the U.S. require an agreement to import bivalve shellfish?
Generally, yes. The FDA only allows bivalve molluscan shellfish from countries that have a shellfish-safety agreement, or memorandum of understanding, with the FDA. We help you understand whether and how your bivalve shellfish can enter the U.S. market.
How is abalone handled?
Abalone is a mollusc and follows Seafood HACCP, with mollusc declared as an allergen and cold-chain and processing controls in place. Unlike bivalves, it isn't covered by the shellfish sanitation program. We map its specific requirements.
What is histamine, and does it affect our fish?
Certain finfish can form histamine, also called scombrotoxin, if not kept cold, which can cause illness. Seafood HACCP plans control it through temperature management. We help you build histamine controls into the plan where they apply.
Why does cold chain matter so much for seafood?
Seafood is highly perishable, and a broken cold chain leads to spoilage, histamine, and pathogen growth. Documented temperature control from harvest through transport is essential, and we help you record it as part of the plan.
What is FSVP, and who is responsible for it?
The Foreign Supplier Verification Program is the U.S. importer's responsibility — they verify that you, the foreign supplier, meet U.S. safety standards. We support both sides: your registration and HACCP plan, and the importer's FSVP, so shipments clear.
What is Prior Notice?
Prior Notice is an electronic notice filed with the FDA before each food shipment arrives in the U.S. It's usually handled on the U.S. side, and we coordinate it with your importer so seafood shipments aren't held at the port of entry.
Do Western Australia grain and agriculture exporters register too?
Yes. WA grain, oilseed, and food producers register as foreign food facilities, appoint a U.S. Agent, and the importer runs FSVP and Prior Notice. We map labeling and safety requirements for those products too.
What happens if a shipment doesn't comply at the U.S. border?
The FDA can refuse admission, detain the shipment, or place it on an import alert, and goods may be re-exported or destroyed. For seafood, a missing HACCP plan, undeclared allergen, or temperature abuse are common triggers, so a review before shipment is essential.
Do labels need to change for the U.S. market?
Usually, yes. U.S. seafood labels must be in English, with the species name, net quantity, allergen declarations including crustacean or molluscan shellfish, and accurate claims. We review and correct labels so products aren't refused for misbranding.
Is Margaret River wine FDA-regulated?
Generally no. Wine and other alcohol are mainly regulated by the U.S. Alcohol and Tobacco Tax and Trade Bureau, not the FDA. We focus on your FDA-regulated seafood and foods and can point you to the right path for wine.
Do supplement and cosmetic exporters register?
Yes. Supplements, including marine-based products, are regulated as foods under Part 111, and under MoCRA the foreign cosmetic manufacturer registers, lists products, and names a Responsible Person. We set up whichever applies.
Do pharmaceutical or device exporters from WA register?
Yes. Foreign drug and device establishments register and list with the FDA, appoint a U.S. Agent, follow cGMP or the device quality system, and use the right pathway. We map the requirements for any WA pharma or device maker.
Does FDA registration mean our product is FDA approved?
No. Registration and listing are mandatory steps that let you enter the U.S. market; they are not FDA approval or endorsement. Claiming “FDA approved” when you are only registered is itself a violation.
Is FDA registration the same as customs rules, and does it renew?
No, and yes. FDA registration is separate from U.S. customs and trade laws, which your importer and broker handle. Foreign food and cosmetic registrations renew biennially, while drug and device registrations renew annually, and we manage every renewal.
How do I get started?
Send us your facility and product details — rock lobster, prawns, abalone, scallops, finfish, grain, supplements, or cosmetics. Contact our team and we'll confirm which FDA requirements apply to your Fremantle business, build your Seafood HACCP plan, address shellfish-program requirements, review labeling, and handle the registration, U.S. Agent appointment, and filings. Email info@fdaregistrationassistance.com or call +1 (928) 275-8333.
