Mysnus Ab

⚠️ High Risk

FEI: 3010465838 • Arlandastad, Stockholms L�n • SWEDEN

FEI

FEI Number

3010465838

📍

Location

Arlandastad, Stockholms L�n

🇸🇪

Country

SWEDEN

🏢

Address

Kabelgatan 5, , Arlandastad, Stockholms L�n, Sweden

High Risk

FDA Import Risk Assessment

55.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/10/2015

Latest Refusal

1/14/2015

Earliest Refusal

Score Breakdown

Violation Severity

80.0×40%

Refusal Volume

43.6×30%

Recency

0.0×20%

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

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).

Refusal History

Date	Product	Violations	Division
2/10/2015	98C06SNUS	3781TPNOWRNLBL	Cincinnati District Office (CIN-DO)
2/10/2015	98C06SNUS	3781TPNOWRNLBL	Cincinnati District Office (CIN-DO)
2/10/2015	98C06SNUS	3781TPNOWRNLBL	Cincinnati District Office (CIN-DO)
2/10/2015	98C06SNUS	3781TPNOWRNLBL	Cincinnati District Office (CIN-DO)
2/10/2015	98C06SNUS	3781TPNOWRNLBL	Cincinnati District Office (CIN-DO)
2/10/2015	98C06SNUS	3781TPNOWRNLBL	Cincinnati District Office (CIN-DO)
2/10/2015	98C06SNUS	3781TPNOWRNLBL	Cincinnati District Office (CIN-DO)
2/10/2015	98C06SNUS	3781TPNOWRNLBL	Cincinnati District Office (CIN-DO)
2/10/2015	98C06SNUS	3781TPNOWRNLBL	Cincinnati District Office (CIN-DO)
2/10/2015	98C06SNUS	3781TPNOWRNLBL	Cincinnati District Office (CIN-DO)
2/10/2015	98C06SNUS	3781TPNOWRNLBL	Cincinnati District Office (CIN-DO)
2/4/2015	98C06SNUS	3781TPNOWRNLBL	Cincinnati District Office (CIN-DO)
1/27/2015	98C06SNUS	3781TPNOWRNLBL	Cincinnati District Office (CIN-DO)
1/14/2015	98C06SNUS	3781TPNOWRNLBL	Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Mysnus Ab's FDA import refusal history?

Mysnus Ab (FEI: 3010465838) has 14 FDA import refusal record(s) in our database, spanning from 1/14/2015 to 2/10/2015.

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. Mysnus Ab's FEI number is 3010465838.

What types of violations has Mysnus Ab received?

Mysnus Ab has been cited for 1 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 Mysnus Ab come from?

All FDA import refusal data for Mysnus 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.