FSVP and FDA Food Facility Registration: Who Does What?

Factory, US agent, US importer, customs broker: who handles each step?

Food brands from Korea preparing for the US often ask us:

"Can our export company register with FDA instead of the factory?"

"Is FSVP a certificate our factory needs to get?"

"Do we need FDA approval before we can sell?"

The short answer: the factory registers with FDA, the US importer runs the FSVP, and whoever has the shipment data files Prior Notice for each shipment. Per FDA's import page, food can be imported without prior FDA approval as long as the facilities that handle it are registered and prior notice is given.

But when one link is missing, the shipment stops.

The 2026 FDA registration renewal runs October 1 to December 31

FDA food facility registrations must be renewed between October 1 and December 31, 2026 (FDA renewal guide). 21 CFR 1.230 sets renewal in every even-numbered year.

Fee: none for registration or renewal, per FDA's September 29, 2026 reminder.
Missed deadline: per the same reminder, FDA treats a registration not renewed by December 31, 2026 as expired.
DUNS number: each registration needs a unique facility identifier (UFI). Per the same reminder, FDA currently accepts the DUNS number from Dun & Bradstreet.

A plant that is already registered still has to renew by December 31, 2026, or its registration expires.

1. FDA food facility registration is the factory's job, not the exporter's

The facility that makes, processes, packs or holds food for the US must register, and 21 CFR 1.230 says it must do so before it starts.

A common mistake is to assume the exporter can register instead. Korea's agri-food export agency, aT, says in its export FAQ that an exporter cannot register in place of an unregistered plant.

Registration follows the plant, not the company name on the invoice. If a contract manufacturer makes your product, check its registration and renewal first.

Food from an unregistered foreign facility is held at the port. Under 21 CFR 1.285, a valid registration number must reach FDA within 30 calendar days of the hold notice. If it does not, the food can only be exported or destroyed.

2. The FDA US agent is the plant's contact point in the US

Every foreign facility must name a US agent, FDA's contact for the facility, when it registers. 21 CFR 1.232 requires the agent's name, full address, phone number and email. Under 21 CFR 1.227, a US agent cannot be a mailbox, an answering machine or service, or any place where no agent is physically present.

Naming a US agent does not take care of the importer's verification duty: the FDA US agent and the FSVP importer are different roles.

3. FSVP is the US importer's duty, not a certificate for the factory

FSVP (Foreign Supplier Verification Program) is the program a US importer runs to verify that food from a foreign supplier meets US safety standards. Per FDA's rule summary, importers need a verification program for each food and each foreign supplier of that food.

The FSVP importer is the US owner or consignee at the time of entry. Under 21 CFR 1.500, that is the person in the US who owns the food, has bought it, or has agreed in writing to buy it. Only when there is no US owner or consignee does the foreign owner's US agent or representative become the importer, with a signed statement of consent.

For example, a US distributor that buys the goods before arrival is the importer. So is your own US company if it brings them in.
At entry: under 21 CFR 1.509, the importer's name, email and DUNS number go on each entry filed with CBP. FDA has required this since July 24, 2022. DUNS numbers are free for importers.
Importer of record: FDA's Import Alert 99-41 notes that the FSVP importer may or may not also be the importer of record.

Foreign supplier verification is not a certificate the factory earns. It is a program the US importer runs. Still, aT's FAQ warns that importers may ask exporters for product safety data, process descriptions and test reports.

4. What does the FSVP importer actually do?

These are the FSVP importer's main duties (FDA's rule summary).

Hazard analysis: identify the hazards the food could carry.
Supplier evaluation: evaluate and approve the plant, then reevaluate at least every 3 years under 21 CFR 1.505.
Verification and corrective action: check the supplier and fix problems.
Records: keep them at least 2 years under 21 CFR 1.510, and produce offsite records within 24 hours of a request.

A qualified individual (QI) does this work. Under 21 CFR 1.500, a QI does not have to be the importer's employee. The rule asks for the education, training or experience the task needs, not a specific course certificate. The same rule says a QI must be able to read the records, so Korean-language documents need a reader on the importer's side.

Small importers get lighter rules. Per FDA's inflation-adjusted cut-offs, a very small importer averages less than $1 million a year, adjusted for inflation: $1,372,952 as the 2023 to 2025 average. Per FDA's rule summary, these importers can skip the hazard analysis and rely on written assurances from suppliers.

5. FDA Prior Notice is filed for every shipment, before arrival

FDA Prior Notice tells FDA about each food shipment before it arrives in the US.

Deadline: under 21 CFR 1.279, at least 2 hours before arrival at the port by road, 4 hours by rail, 4 hours by air and 8 hours by water.
Earliest filing: 15 calendar days ahead through FDA's PNSI system, or 30 days through CBP's ABI/ACE.
Who files: under 21 CFR 1.278, anyone who knows the required information can submit it, or have another person (a transmitter) send it. In practice, the customs broker often transmits it with the entry.
Registration number: per FDA's CPG 110.310, FDA intends to reject Prior Notice that lacks the manufacturer's valid registration number or an allowed reason.

Food with no Prior Notice, or a late or inaccurate one, is subject to refusal (CPG 110.310). Duty is a separate question, set by the product's HTS code.

For samples sent by international mail, FDA requires the mail service name and tracking number from October 1, 2026, but does not expect them until May 1, 2027.

6. Kimchi, sauces and canned food: check acidified and LACF status product by product

Whether kimchi, a sauce or a canned product falls under the acidified food or low-acid canned food (LACF) rules depends on its pH, water activity (aw) and whether acid is added, not on its name. Under 21 CFR 114.3, a low-acid food has a finished pH above 4.6 and aw above 0.85. An acidified food is a low-acid food with acid added, a finished pH of 4.6 or below and aw above 0.85.

If the rules apply, 21 CFR 108.25 requires a foreign processor to register on Form FDA 2541 (a Food Canning Establishment, or FCE, registration) before offering food for import. It must file each scheduled process (SID) within 60 days after registration and before packing a new product; acidified foods use Form FDA 2541e. Per FDA's Importing Human Foods page, FDA checks both at entry, and products from firms without them are subject to refusal.

FDA's import alert list for Korea includes alerts that detain acidified foods and LACF without physical examination (DWPE) for missing scheduled processes (99-37) or inadequate process control (99-38). Have a process authority check each product before you decide whether these rules apply.

7. Why FDA refuses Korean food: products and labels more than paperwork

Most refusals of Korean food come from the product and the label, not from registration paperwork. An analysis of FDA import refusal data by fruit-risk.com counts 470 refused entries from South Korea in 2020 to 2025. That is 2.1% of 22,156 US food refusals, and 63% of the Korean refusals were hazard findings. Korean press reports count differently and give different numbers.

The most-cited charges in the same analysis (2020 to 2025):

Listeria 83, undeclared allergen 61
Ingredients not listed 82, nutrition labeling 82, not in English 78
No process filing 32, FSVP violation 27 (22 of them in 2024)

FDA's Korea alert list includes Import Alert 25-21, which detains enoki mushrooms from Korea and China without examination because of Listeria. Korean outlet The Guru reported dried persimmons refused for undeclared sulfur dioxide.

Under Import Alert 99-41, FDA may also refuse food when the importer does not meet its supplier verification requirements. Food Safety News reported in August 2026 that FDA sent warning letters to three California food importers over foreign supplier verification failures.

Registration gets your food to the border. Product safety and labels get it through. We cover labels in FDA labeling requirements.

Who does what: factory, US agent, FSVP importer, customs broker

The foreign factory registers with FDA, the US importer runs the FSVP, and the customs broker often transmits Prior Notice.

Role	FDA facility registration	2026 renewal	FSVP	Prior Notice
Foreign factory	Registers; needs a DUNS number and a US agent	October 1 to December 31, no fee	Supplies safety data, process descriptions, test reports	Its registration number is required
FDA US agent	Listed as the contact	The factory renews	Importer only if there is no US owner or consignee, with signed consent	Can file if it has the data
FSVP importer (US owner or consignee)	No duty	No duty	Runs a verification program per food and supplier; keeps records 2 years	Can file if it has the data
Customs broker	No duty	No duty	Enters the importer's name, email and DUNS on the entry	Often transmits it with the entry

Four things to check before your first shipment

Check these four points before the first shipment leaves.

1. Has the factory renewed its FDA registration before December 31, 2026?

2. Who is the US importer at entry that must verify your factory, and does it have a DUNS number?

3. Who files Prior Notice, and what is the deadline for your mode of transport?

4. Have you checked pH and water activity to see whether the acidified food or LACF rules apply?

Wrap-up

Food shipments usually get stuck where nobody owns a step: the factory thinks the exporter registered it, the exporter thinks the US buyer handles supplier verification, and the buyer thinks the supplier did everything. In 2026, start with the December 31 renewal deadline.

LinkONE supports FDA facility registration, SID registration, FSVP documentation and US customs clearance from its warehouse in Fullerton, California.

In the end, exporting food to the US is not about FDA approval. It is about the factory, the importer and the broker each finishing their part.

Frequently Asked Questions

What does FSVP stand for?

FSVP stands for Foreign Supplier Verification Program, the program a US importer runs to verify that food from each foreign supplier meets US safety standards (FDA). The importer needs an FSVP for each food and each supplier. It is not a certificate the factory holds; the factory supplies safety data and test reports when the importer asks (aT FAQ).

Do food products need FDA approval?

Imported food does not need FDA approval in advance, but the facilities that handle it must be registered and each shipment needs Prior Notice (FDA). Acidified foods and LACF also need an FCE registration and a process filing, which FDA checks at entry (FDA).

When is the 2026 FDA food facility registration renewal?

The 2026 renewal window runs from October 1 to December 31, 2026 (FDA renewal guide). There is no fee, and registrations not renewed by December 31 expire (FDA reminder, September 29, 2026). Renewal comes every even-numbered year (21 CFR 1.230).

Who is eligible to be an FSVP importer?

The FSVP importer is the US owner or consignee at entry: the person in the US who owns the food, has bought it, or has agreed in writing to buy it (21 CFR 1.500). If there is none, the foreign owner's US agent or representative becomes the importer by signing a statement of consent. The FSVP importer may or may not be the importer of record (Import Alert 99-41).

Does kimchi or a sauce need LACF or acidified food registration?

Whether kimchi or a sauce needs it depends on each product's pH, water activity and added acid. 21 CFR 114.3 defines an acidified food as a low-acid food with acid added, a finished pH of 4.6 or below and aw above 0.85. If the rules apply, the processor needs an FCE registration and a process filing (21 CFR 108.25), so have a process authority check the product.

Sources

Fees and rules in this post are as of October 2026.

-LinkONE-