FDA Import Refusal Database
Search 500,000+ FDA import refusal records from 2001 to present. Find firms, violations, and regulatory actions.
Data from 10/1/2001 to 12/23/2025
Top Firms by Refusals
View all →Juarez, MEXICO
Stockholm, SWEDEN
Ciudad De Mexico, MEXICO
Cuauhtemoc, MEXICO
Jiading, CHINA
Sialkot, PAKISTAN
Changodar, INDIA
Malmo, SWEDEN
Molendinar, AUSTRALIA
Birmingham, UNITED KIN
Common Violations
View all →NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
UNAPPROVED
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).
FILTHY
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 unfit for food.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
FRNMFGREG
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. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
SALMONELLA
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.
NO 510(K)
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 substantially equivalent or otherwise filed.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Recent Refusals
View all →| Date | Firm | Product | Violations |
|---|---|---|---|
| 12/23/2025 | CBI SRO | NICOTINE POUCH | |
| 12/23/2025 | TIN JAR AB | NICOTINE POUCH | |
| 12/23/2025 | PHILIP MORRIS AB | NICOTINE POUCH | |
| 12/23/2025 | PHILIP MORRIS AB | NICOTINE POUCH | |
| 12/23/2025 | NGP TOBACCO | NICOTINE POUCH | 3842TP NO PMTA |
Explore the FDA Import Refusal Database
Access comprehensive data on FDA enforcement actions
Frequently Asked Questions
What is an FDA import refusal?
An FDA import refusal occurs when the U.S. Food and Drug Administration detects that an imported product appears to violate U.S. laws and regulations. When this happens, the product is refused entry into the United States. Common reasons include adulteration, misbranding, lack of required registration, or failure to meet safety standards.
Where does this FDA import refusal data come from?
All data on ImportRefusal.com is sourced directly from the official FDA Data Dashboard (datadashboard.fda.gov), a publicly available government database maintained by the U.S. Food and Drug Administration. The data is updated monthly.
How far back does the FDA import refusal data go?
Our database contains FDA import refusal records from 2001 to the present, with over 500,000 records covering firms, violations, and products from countries around the world.
What can I search for on ImportRefusal.com?
You can search for firms by name or FEI number, browse violation codes, filter by country of origin, and explore specific products that have been refused entry. Each firm page shows their complete refusal history and associated violations.
Does an import refusal mean a company is unsafe?
Not necessarily. An import refusal indicates that a specific shipment appeared to violate FDA requirements at the time of import. Many firms resolve issues and subsequently have successful imports. Always verify current compliance status with official FDA sources before making business decisions.