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YOIK AB

🚨 Critical Risk

FEI: 3019418971 β€’ Gemla β€’ SWEDEN

FEI

FEI Number

3019418971

πŸ“

Location

Gemla

πŸ‡ΈπŸ‡ͺ

Country

SWEDEN
🏒

Address

N 136, 355 99, , Gemla, , Sweden

Critical Risk

FDA Import Risk Assessment

79.6
LowModerateHighCritical

This firm has an extensive history of FDA import refusals with severe violations.

Statistics

282
Total Refusals
7
Unique Violations
12/29/2025
Latest Refusal
8/22/2024
Earliest Refusal

Score Breakdown

Violation Severity
56.2Γ—40%
Refusal Volume
90.8Γ—30%
Recency
99.4Γ—20%
Frequency
100.0Γ—10%
How is this score calculated?

Proprietary Algorithm

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

Β© ImportRefusal.com Original Analysis

Violation Summary

3842262Γ—

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.

3843185Γ—

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).

385467Γ—

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.

35205Γ—

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.

38514Γ—

TPLACKFIRM

This article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(A) of the FD&C Act in that the label does not contain the name and place of business of the tobacco product manufacturer, packer or distributor.

38522Γ—

TPLACKSNC

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 in package form that appears to be misbranded under section 903(a)(2)(B) of the FD&C Act in that the label does not provide an accurate statement of the quantity of contents in terms of weight, measure or numerical count.

38941Γ—

TPNICWARN

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 appears to be misbranded under section 903(a)(7)(B) in that it is sold or distributed in violation of regulations prescribed under 906(d), namely its package fails to bear the required warning statement "WARNING: This product contains nicotine. Nicotine is an addictive chemical." Or if applicable the required statement "This product is made from tobacco."

Refusal History

DateProductViolationsDivision
12/29/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
12/29/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
12/29/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
12/19/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
12/19/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
12/19/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
12/17/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
12/15/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
12/9/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
12/9/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
12/9/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
12/9/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
12/8/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
12/8/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
12/8/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
12/8/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
12/8/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
12/8/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
12/8/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
12/8/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
12/8/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
12/5/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
12/4/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
12/3/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
11/25/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
11/21/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
11/21/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
11/14/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
11/14/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
11/14/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
11/14/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
11/14/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
11/14/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
11/14/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
11/13/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
11/12/2025
98NCA11NICOTINE POUCH
3852TPLACKSNC
Division of Southeast Imports (DSEI)
11/12/2025
98NCA11NICOTINE POUCH
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
11/10/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
11/10/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
11/10/2025
98NCA11NICOTINE POUCH
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
11/10/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
11/10/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
11/10/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
11/7/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
11/7/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
11/6/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
11/6/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
11/6/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
11/6/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
11/6/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
11/4/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
11/4/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
10/31/2025
98CCA06SNUS
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/31/2025
98NCA11NICOTINE POUCH
3854TPLKUSSLLB
Division of Southeast Imports (DSEI)
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)
10/27/2025
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)
10/27/2025
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)
10/27/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/24/2025
98NCA99NICOTINE DELIVERY PRODUCT, NEC
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
10/22/2025
98NBA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/22/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/21/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
10/21/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
10/21/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/21/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
10/21/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
10/21/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
10/21/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
10/20/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/17/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
10/17/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
10/17/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
10/17/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
10/17/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Northeast Imports (DNEI)
10/15/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/15/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/15/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/15/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)
10/15/2025
98NCA11NICOTINE POUCH
3842TP NO PMTA
3843TP NO SE
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is YOIK AB's FDA import refusal history?

YOIK AB (FEI: 3019418971) has 282 FDA import refusal record(s) in our database, spanning from 8/22/2024 to 12/29/2025.

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. YOIK AB's FEI number is 3019418971.

What types of violations has YOIK AB received?

YOIK AB has been cited for 7 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 YOIK AB come from?

All FDA import refusal data for YOIK AB 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.