21 CFR 207.69

FDA U.S. Agent for drug establishments in Japan

A drug establishment in Japan that exports to the United States must register with FDA and name a U.S. Agent located in the U.S. (21 CFR 207.69). In the 12 months from 2025-10 to 2026-09, FDA refused 283 import lines from Japan, and 42 FDA import alerts list firms from Japan.

FDA data for Japan

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	283
Refusals citing registration or listing problems	NOT LISTED-118 · 114 FRNMFGREG-3280 · 107 REGISTERED-341 · 23

Most refused product industries

Code		Count
66	Human and Animal Drugs	40
61	Human and Animal Drugs	15

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…	114
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…	107
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…	52
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).	36
REGISTERED-341 The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears the device is subject to listing under 510(j) and the initial distributor has not regis…	23

Import alerts listing Japan firms

Import alerts that list at least one firm in Japan: 42. Recently updated:

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
Import Alert 99-05: Detention Without Physical Examination Of Raw Agricultural Products for Pesticides
Import Alert 99-08: Detention without Physical Examination of Processed Human and Animal Foods for Pesticides
Import Alert 99-19: Detention Without Physical Examination of Food Products Due to the Presence of Salmonella

Recalls by Japan firms, last 5 years

5 (Class III: 4, Class II: 1)

Recent recall reasons:

2026-02 Failed Disintegration Specifications: above the time expected.
2024-05 Cross Contamination with Other Products

What the rule requires

A foreign establishment that manufactures, repacks, relabels or salvages a drug imported or offered for import into the United States must register with FDA electronically, list its drugs, and identify a U.S. Agent who lives or has a place of business in the U.S. Registration is renewed each year between October 1 and December 31.

Foreign manufacturers of finished human and animal drugs, including OTC products and hand sanitizers
Foreign API manufacturers, repackers and relabelers whose products are imported into the U.S.

Deadlines

Register within 5 calendar days after beginning operations (21 CFR 207.21)
Renew annually between October 1 and December 31 (21 CFR 207.29)
Update drug listings each June and December, or certify no changes

Steps

Get a DUNS number for the establishment
Request a labeler code if you will list products under your own name
Prepare Structured Product Labeling (SPL) files for registration and listing
Submit through FDA's Electronic Submissions Gateway or CDER Direct
The U.S. Agent is named in the registration and FDA contacts them to confirm

Common mistakes

Submitting SPL with a DUNS whose address does not match
Missing the year-end listing certification
Assuming registration or an NDC number means FDA approved the drug. It does not

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.