21 CFR 1.227, 1.230–1.235

FDA U.S. Agent for food facilitys in Mexico

A food facility in Mexico 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 2,427 import lines from Mexico, and 70 FDA import alerts list firms from Mexico.

FDA data for Mexico

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	2,427
Refusals citing registration or listing problems	NOT LISTED-118 · 266

Most refused product industries

Code		Count
07	Snack Food Items	737
24	Vegetables/Vegetable Products	212
54	Vitamins/Minerals (Human/Animal); Proteins/Unconv Dietary Supp (Human)	152
21	Fruit/Fruit Products	147

Most common refusal charges

Code	Count
UNSAFE COL-11 The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).	795
COLOR LBLG-274 The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.	791
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).	633
NO ENGLISH-324 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 within the meaning of Section 403(f) of the FD&C Act in that any word,…	324
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…	266

Import alerts listing Mexico firms

Import alerts that list at least one firm in Mexico: 70. Recently updated:

Import Alert 16-129: Detention Without Physical Examination of Seafood Products Due to Nitrofurans
Import Alert 16-39: Detention Without Physical Examination of Ready-to-Eat Seafood for Listeria monocytogenes
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 Mexico firms, last 5 years

33 (Class I: 23, Class III: 9, Class II: 1)

Recent recall reasons:

2026-08 Potential Cyclospora contamination.
2026-01 pathogen Cyclospora cayetanensis
2025-08 Multiple cake products contain goat milk, which was labeled as "milk"

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.