Luxana Perfumes
⚠️ Moderate Risk
FEI: 3007198388 • Barcelona, Barcelona • SPAIN
FEI Number
3007198388
Location
Barcelona, Barcelona
Country
SPAINAddress
Via Augusta 158 6 1, , Barcelona, Barcelona, Spain
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
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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 |
|---|---|---|---|
| 9/28/2012 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 9/28/2012 | 53ED99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C. | 471CSTIC LBLG | Florida District Office (FLA-DO) |
| 9/28/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Luxana Perfumes's FDA import refusal history?
Luxana Perfumes (FEI: 3007198388) has 3 FDA import refusal record(s) in our database, spanning from 9/28/2012 to 9/28/2012.
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. Luxana Perfumes's FEI number is 3007198388.
What types of violations has Luxana Perfumes received?
Luxana Perfumes 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 Luxana Perfumes come from?
All FDA import refusal data for Luxana Perfumes 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.