Europa Plus
⚠️ Moderate Risk
FEI: 3009428881 • Dnipropetrovsk, Dnipropetrovska • UKRAINE
FEI Number
3009428881
Location
Dnipropetrovsk, Dnipropetrovska
Country
UKRAINEAddress
Korniychuka Vul 4, Suite # 94, Dnipropetrovsk, Dnipropetrovska, Ukraine
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/18/2013 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Chicago District Office (CHI-DO) | |
| 4/18/2013 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Chicago District Office (CHI-DO) | |
| 4/18/2013 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Chicago District Office (CHI-DO) | |
| 4/18/2013 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Chicago District Office (CHI-DO) | |
| 4/18/2013 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Chicago District Office (CHI-DO) | |
| 4/18/2013 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Chicago District Office (CHI-DO) | |
| 4/18/2013 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 4/18/2013 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Chicago District Office (CHI-DO) | |
| 4/18/2013 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Chicago District Office (CHI-DO) | |
| 4/18/2013 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Chicago District Office (CHI-DO) | |
| 4/18/2013 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Chicago District Office (CHI-DO) | |
| 12/20/2012 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | Chicago District Office (CHI-DO) | |
| 12/20/2012 | 66VBO99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) | |
| 12/20/2012 | 66VCH99MISCELLANEOUS PATENT MEDICINES, ETC. | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Europa Plus's FDA import refusal history?
Europa Plus (FEI: 3009428881) has 14 FDA import refusal record(s) in our database, spanning from 12/20/2012 to 4/18/2013.
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. Europa Plus's FEI number is 3009428881.
What types of violations has Europa Plus received?
Europa Plus 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 Europa Plus come from?
All FDA import refusal data for Europa Plus 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.