21 CFR 1.227, 1.230–1.235

FDA U.S. Agent for food facilitys in South Korea

A food facility in South Korea that exports to the United States must register with FDA and name a U.S. Agent located in the U.S. (21 CFR 1.227, 1.230–1.235). In the 12 months from 2025-10 to 2026-09, FDA refused 1,347 import lines from South Korea, and 51 FDA import alerts list firms from South Korea.

FDA data for South Korea

Figures from FDA public data, retrieved 2026-10-21. Recall counts are by the recalling firm's country.

Import refusals, 2025-10 to 2026-09

Refused import lines	1,347
Refusals citing registration or listing problems	NOT LISTED-118 · 507 FRNMFGREG-3280 · 439

Most common refusal charges

Code	Count
NOT LISTED-118 The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. Based on the information…	507
FRNMFGREG-3280 The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. Based on information available to FDA, i…	439
UNAPPROVED-75 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).	317
NO 510(K)-508 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantial…	206
NO PMA-237 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for prem…	201

Import alerts listing South Korea firms

Import alerts that list at least one firm in South Korea: 51. Recently updated:

Import Alert 16-39: Detention Without Physical Examination of Ready-to-Eat Seafood for Listeria monocytogenes
Import Alert 20-07: Detention Without Physical Examination of Juice from Foreign Processors Not in Compliance with Juice HACCP Regulation
Import Alert 45-02: Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors.
Import Alert 45-06: Detention without Physical Examination of Stevia Leaves, Crude Extracts of Stevia Leaves and foods Containing Stevia Leaves and/or Stevia Extracts

Recalls by South Korea firms, last 5 years

3 (Class II: 3)

Recent recall reasons:

2026-08 Foreign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in Frozen Flounder Products.
2026-08 Product label allergen "contains" statement does not include anchovy(fish)

What the rule requires

Every foreign facility that manufactures, processes, packs or holds food for consumption in the United States must register with FDA and name a U.S. Agent who lives or keeps a place of business in the U.S. and is physically present there. Registrations must be renewed between October 1 and December 31 of each even-numbered year.

Foreign facilities that manufacture, process, pack or hold food, beverages, dietary supplements or animal food for U.S. consumption
Exempt: facilities whose food undergoes further manufacturing or processing (beyond labeling or a de minimis step) at another foreign facility before export, under 21 CFR 1.226(a)

Deadlines

Register before the facility starts handling food for the U.S. market
Renew every even-numbered year, October 1 to December 31 (21 CFR 1.230(b))
Update within 60 days of any change to required information, including the U.S. Agent (21 CFR 1.234)

Steps

Get a Unique Facility Identifier (UFI). FDA currently accepts the DUNS number
Choose a U.S. Agent and get their written agreement
Your owner, operator or agent in charge submits the registration in FDA's FURLS Food Facility Registration Module
FDA emails the U.S. Agent to verify the designation; the agent confirms
Keep your registration number for prior notice filings

Common mistakes

Listing a U.S. Agent who never agreed to serve. FDA verifies the agent and may cancel the registration
Missing the even-year renewal, which makes the registration expire
Using an invalid or mismatched DUNS address
Buying a "registration certificate": FDA does not issue them

How US Agent Desk helps

We serve as your U.S. Agent, prepare the registration data in your language for your company's officer to submit, confirm the designation when FDA asks, and check FDA's public records for your company every morning. Prices start at $990 per year.

Check if you need a U.S. Agent See prices

Sources

Independent private service. Not affiliated with the U.S. FDA. Not legal advice.