21 CFR 207.69

FDA U.S. Agent for drug establishments in India

A drug establishment in India 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 5,683 import lines from India, and 58 FDA import alerts list firms from India.

FDA data for India

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	5,683
Refusals citing registration or listing problems	NOT LISTED-118 · 907

Most refused product industries

Code		Count
66	Human and Animal Drugs	813
61	Human and Animal Drugs	732
62	Human and Animal Drugs	489

Most common refusal charges

Code	Count
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).	3260
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…	907
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…	563
MFR INJ-3821 The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (the Act) in that such article appears to have been prepared, packed, or held …	549
MFR INSAN-308 The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.	518

Import alerts listing India firms

Import alerts that list at least one firm in India: 58. Recently updated:

Import Alert 16-129: Detention Without Physical Examination of Seafood Products Due to Nitrofurans
Import Alert 45-02: Detention Without Physical Examination and Guidance of Foods Containing Illegal and/or Undeclared Colors.
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
Import Alert 99-42: DETENTION WITHOUT PHYSICAL EXAMINATION OF FOODS DUE TO HEAVY METAL (TOXIC ELEMENT) CONTAMINATION

Recalls by India firms, last 5 years

222 (Class II: 186, Class I: 26, Class III: 10)

Recent recall reasons:

2026-10 Lack of Assurance of Sterility
2026-09 Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
2026-08 Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials

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.