Arcon Scandinavia Aps
✅ Low Risk
FEI: 3003756556 • Esbjerg • DENMARK
FEI Number
3003756556
Location
Esbjerg
Country
DENMARKAddress
Jyllandsgade 33, , Esbjerg, , Denmark
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
Statistics
Score Breakdown
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
INCONSPICU
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 (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/26/2006 | 54FBE45FENUGREEK (HERBAL & BOTANICALS, NOT TEAS) | 256INCONSPICU | Cincinnati District Office (CIN-DO) |
| 1/13/2006 | 54FBE45FENUGREEK (HERBAL & BOTANICALS, NOT TEAS) | 256INCONSPICU | Cincinnati District Office (CIN-DO) |
| 8/23/2004 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Arcon Scandinavia Aps's FDA import refusal history?
Arcon Scandinavia Aps (FEI: 3003756556) has 3 FDA import refusal record(s) in our database, spanning from 8/23/2004 to 1/26/2006.
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. Arcon Scandinavia Aps's FEI number is 3003756556.
What types of violations has Arcon Scandinavia Aps received?
Arcon Scandinavia Aps has been cited for 2 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 Arcon Scandinavia Aps come from?
All FDA import refusal data for Arcon Scandinavia Aps 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.