ImportRefusal LogoImportRefusal

NICOTECH OU

⚠️ High Risk

FEI: 3037284246 • Harjumaa • ESTONIA

FEI

FEI Number

3037284246

📍

Location

Harjumaa

🇪🇪

Country

ESTONIA
🏢

Address

Suurvalja Tee 5, , Harjumaa, , Estonia

High Risk

FDA Import Risk Assessment

70.3
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

67
Total Refusals
4
Unique Violations
12/18/2025
Latest Refusal
5/22/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.4×40%
Refusal Volume
67.9×30%
Recency
98.7×20%
Frequency
100.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

384262×

TP NO PMTA

This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be adulterated under section 902(6)(A) of the FD&C Act in that it does not have an FDA marketing order in effect under section 910(c)(1)(A)(i) of the FD&C Act.

384351×

TP NO SE

This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that FDA has found to be misbranded under section 903(a)(6) of the FD&C Act in that a notice or other information respecting it was not provided as required by section 905(j).

385444×

TPLKUSSLLB

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(D) of the FD&C Act in that the label does not provide the statement "sale only allowed in the United States" and the tobacco product is not subject to any exemptions or variations.

35205×

TP FLAVOR

This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it is, or purports to be or is represented as, a tobacco product that is subject to a tobacco product standard established under section 907, and violates 907 (a) (1) (A) in that the article appears to contain, as a constituent or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, that is a characterizing flavor of the tobacco product or tobacco smoke.

Refusal History

DateProductViolationsDivision
12/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
12/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
12/18/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
12/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
12/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
11/19/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
10/27/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/27/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/15/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/7/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
10/7/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
9/26/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
9/26/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
9/25/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
9/23/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
9/23/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
9/23/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
9/18/2025
98NCA11NICOTINE POUCH
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
9/18/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
9/5/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
9/4/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
9/4/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
9/4/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
9/4/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
9/4/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
8/29/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/29/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/29/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/29/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/29/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/29/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
8/27/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/27/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/27/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/27/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/26/2025
98NBA11NICOTINE POUCH
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/26/2025
98NBA11NICOTINE POUCH
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/26/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/26/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/26/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/26/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/26/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/26/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/22/2025
98NCA11NICOTINE POUCH
3520TP FLAVOR
3842TP NO PMTA
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/22/2025
98NCA11NICOTINE POUCH
3520TP FLAVOR
3842TP NO PMTA
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/21/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/21/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/21/2025
98CCA16SMOKELESS TOBACCO POUCHES
3520TP FLAVOR
3842TP NO PMTA
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/21/2025
98NCA11NICOTINE POUCH
3520TP FLAVOR
3842TP NO PMTA
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/13/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/13/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
8/13/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
8/11/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/11/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/8/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
8/8/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
8/8/2025
98NCA11NICOTINE POUCH
3520TP FLAVOR
3842TP NO PMTA
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/5/2025
98NCA11NICOTINE POUCH
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
8/1/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
8/1/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
7/31/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
7/24/2025
98NCA11NICOTINE POUCH
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
7/23/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
7/21/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
6/20/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
5/30/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
5/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is NICOTECH OU's FDA import refusal history?

NICOTECH OU (FEI: 3037284246) has 67 FDA import refusal record(s) in our database, spanning from 5/22/2025 to 12/18/2025.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. NICOTECH OU's FEI number is 3037284246.

What types of violations has NICOTECH OU received?

NICOTECH OU has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about NICOTECH OU come from?

All FDA import refusal data for NICOTECH OU is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.