Ilcsi Szepitoe Fuvek Biokozmetikai
⚠️ High Risk
FEI: 3003735006 • Budapest IX, Budapest • HUNGARY
FEI Number
3003735006
Location
Budapest IX, Budapest
Country
HUNGARYAddress
Ulloi ut 37., U., Budapest IX, Budapest, Hungary
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 4/1/2014 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 12/10/2012 | 65LDL99PROTECTANT N.E.C. | Chicago District Office (CHI-DO) | |
| 9/25/2012 | 66PBK99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Chicago District Office (CHI-DO) |
| 3/25/2011 | 65LIL99PROTECTANT N.E.C. | New Orleans District Office (NOL-DO) | |
| 9/21/2010 | 66PMK99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Ilcsi Szepitoe Fuvek Biokozmetikai's FDA import refusal history?
Ilcsi Szepitoe Fuvek Biokozmetikai (FEI: 3003735006) has 25 FDA import refusal record(s) in our database, spanning from 9/21/2010 to 4/1/2014.
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. Ilcsi Szepitoe Fuvek Biokozmetikai's FEI number is 3003735006.
What types of violations has Ilcsi Szepitoe Fuvek Biokozmetikai received?
Ilcsi Szepitoe Fuvek Biokozmetikai has been cited for 7 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 Ilcsi Szepitoe Fuvek Biokozmetikai come from?
All FDA import refusal data for Ilcsi Szepitoe Fuvek Biokozmetikai 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.