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Gotlandssnus

⚠️ High Risk

FEI: 3008733212 • Romakloster • SWEDEN

FEI

FEI Number

3008733212

📍

Location

Romakloster

🇸🇪

Country

SWEDEN
🏢

Address

Sockerbraket Roma, , Romakloster, , Sweden

High Risk

FDA Import Risk Assessment

56.7
LowModerateHighCritical

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

Statistics

17
Total Refusals
5
Unique Violations
3/21/2024
Latest Refusal
1/14/2015
Earliest Refusal

Score Breakdown

Violation Severity
70.5×40%
Refusal Volume
46.5×30%
Recency
63.8×20%
Frequency
18.5×10%
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

378114×

TPNOWRNLBL

This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it is a tobacco product which appears to be misbranded under section 903(a)(8)(B)(i) and 903(a)(1) because its package label does not include a brief statement of the relevant warnings (i.e., one of the four warnings required by section 3 of the Comprehensive Smokeless Tobacco Health Education Act).

38423×

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.

38432×

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).

38542×

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.

35201×

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
3/21/2024
98CCA06SNUS
3520TP FLAVOR
3842TP NO PMTA
Division of Southeast Imports (DSEI)
2/22/2024
98CCA06SNUS
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Northeast Imports (DNEI)
2/22/2024
98CCA06SNUS
3842TP NO PMTA
3843TP NO SE
3854TPLKUSSLLB
Division of Northeast Imports (DNEI)
2/17/2015
98C06SNUS
3781TPNOWRNLBL
Cincinnati District Office (CIN-DO)
2/17/2015
98C06SNUS
3781TPNOWRNLBL
Cincinnati District Office (CIN-DO)
2/5/2015
98C06SNUS
3781TPNOWRNLBL
Cincinnati District Office (CIN-DO)
2/2/2015
98C06SNUS
3781TPNOWRNLBL
Cincinnati District Office (CIN-DO)
2/2/2015
98C06SNUS
3781TPNOWRNLBL
Cincinnati District Office (CIN-DO)
2/2/2015
98C06SNUS
3781TPNOWRNLBL
Cincinnati District Office (CIN-DO)
1/23/2015
98C06SNUS
3781TPNOWRNLBL
Cincinnati District Office (CIN-DO)
1/23/2015
98C06SNUS
3781TPNOWRNLBL
Cincinnati District Office (CIN-DO)
1/21/2015
98C06SNUS
3781TPNOWRNLBL
Cincinnati District Office (CIN-DO)
1/20/2015
98C06SNUS
3781TPNOWRNLBL
Cincinnati District Office (CIN-DO)
1/20/2015
98C06SNUS
3781TPNOWRNLBL
Cincinnati District Office (CIN-DO)
1/20/2015
98C06SNUS
3781TPNOWRNLBL
Cincinnati District Office (CIN-DO)
1/16/2015
98C06SNUS
3781TPNOWRNLBL
Cincinnati District Office (CIN-DO)
1/14/2015
98C06SNUS
3781TPNOWRNLBL
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Gotlandssnus's FDA import refusal history?

Gotlandssnus (FEI: 3008733212) has 17 FDA import refusal record(s) in our database, spanning from 1/14/2015 to 3/21/2024.

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. Gotlandssnus's FEI number is 3008733212.

What types of violations has Gotlandssnus received?

Gotlandssnus has been cited for 5 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 Gotlandssnus come from?

All FDA import refusal data for Gotlandssnus 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.