21 CFR 1.227, 1.230–1.235

FDA U.S. Agent for food facilitys in Pakistan

A food facility in Pakistan 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 407 import lines from Pakistan, and 26 FDA import alerts list firms from Pakistan.

FDA data for Pakistan

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	407
Refusals citing registration or listing problems	NOT LISTED-118 · 26

Most refused product industries

Code		Count
16	Fishery/Seafood Products	35
02	Whole Grains/Milled Grain Products/Starches	29

Most common refusal charges

Code	Count
DE IMP GMP-290 The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not …	236
SALMONELLA-9 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.	32
PESTICIDE-241 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the …	29
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…	26
FILTHY-249 The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise un…	24

Import alerts listing Pakistan firms

Import alerts that list at least one firm in Pakistan: 26. Recently updated:

Import Alert 45-02: Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors.

Recalls by Pakistan firms, last 5 years

1 (Class II: 1)

Recent recall reasons:

2024-08 Products contain elevated levels of lead.

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.