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Simris Alg

✅ Low Risk

FEI: 3012558800 • Hammenhog, Skane Lan • SWEDEN

FEI

FEI Number

3012558800

📍

Location

Hammenhog, Skane Lan

🇸🇪

Country

SWEDEN
🏢

Address

Herrestadsvagen 24a, , Hammenhog, Skane Lan, Sweden

Low Risk

FDA Import Risk Assessment

24.7
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

3
Total Refusals
4
Unique Violations
1/17/2018
Latest Refusal
1/17/2018
Earliest Refusal

Score Breakdown

Violation Severity
37.5×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

23003×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

38643×

NCONTACT

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

38653×

COLORLABEL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use.

4823×

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.

Refusal History

DateProductViolationsDivision
1/17/2018
54HYY05OMEGA-3 (FATS AND LIPID SUBSTANCES)
2300DIETARYLBL
3864NCONTACT
3865COLORLABEL
482NUTRIT LBL
Division of Southeast Imports (DSEI)
1/17/2018
54HYY05OMEGA-3 (FATS AND LIPID SUBSTANCES)
2300DIETARYLBL
3864NCONTACT
3865COLORLABEL
482NUTRIT LBL
Division of Southeast Imports (DSEI)
1/17/2018
54HYY05OMEGA-3 (FATS AND LIPID SUBSTANCES)
2300DIETARYLBL
3864NCONTACT
3865COLORLABEL
482NUTRIT LBL
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Simris Alg's FDA import refusal history?

Simris Alg (FEI: 3012558800) has 3 FDA import refusal record(s) in our database, spanning from 1/17/2018 to 1/17/2018.

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. Simris Alg's FEI number is 3012558800.

What types of violations has Simris Alg received?

Simris Alg 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 Simris Alg come from?

All FDA import refusal data for Simris Alg 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.