Who has to register
Any foreign facility that manufactures, processes, packs, or holds seafood intended for US consumption must register with FDA under the Food Facility Registration requirements, renewed on FDA's shared biennial calendar. This applies to processing plants, cold-storage facilities that repack or relabel product, and in many cases vessels that process catch on board.
Registration is a facility-level requirement — it identifies who is producing what, and where, so FDA can trace a shipment back to its source. It does not, by itself, certify that the facility's food-safety practices meet any particular standard. That's a separate, substantive obligation covered by the Seafood HACCP regulation.
The US Agent
Every foreign-registered facility must appoint a US Agent — a person or firm physically located in the United States who acts as FDA's point of contact for that facility. The US Agent isn't a rubber-stamp role: FDA can and does contact the US Agent directly during an inspection, an import alert review, or a facility follow-up, so it needs to be someone who can actually respond and coordinate on the facility's behalf.
Product codes and entry data
At the time of import, US Customs and Border Protection entry filings for seafood require an FDA product code that correctly identifies the species and product form (fresh, frozen, canned, smoked, etc.), along with the facility's registration number. A mismatch between the product code, the market name on the label, and what's declared on the Prior Notice is one of the more common triggers for a hold at port.
Registration ≠ HACCP compliance
Registering a facility with FDA and operating that facility in compliance with the Seafood HACCP regulation (21 CFR Part 123) are two different obligations. A registered facility that hasn't implemented a valid HACCP plan is still out of compliance — and the importer of record is the one FDA holds accountable at the border. See our Seafood HACCP importer verification guide for what the importer-side program actually requires.
What US importers need on file
- Confirmation the foreign facility is currently registered (registration numbers can lapse on the biennial renewal window)
- The facility's HACCP plan, in English, on file per the importer-verification requirement
- A named FSVP/HACCP-equivalent importer of record for entry filing purposes
- Prior Notice filed and confirmed before the shipment arrives
Frequently asked
Do foreign seafood processors need FDA facility registration?
Yes — any facility manufacturing, processing, packing, or holding seafood for the US market must register and appoint a US Agent, the same as any other food category.
Is FDA facility registration the same as Seafood HACCP compliance?
No. Registration identifies the facility. HACCP compliance under 21 CFR Part 123 is the substantive food-safety program the facility has to operate and document separately.