Alcantara Espana Sa
⚠️ Moderate Risk
FEI: 3001621087 • Salamanca, Salamanca • SPAIN
FEI Number
3001621087
Location
Salamanca, Salamanca
Country
SPAINAddress
Calle Arribes del Duero, No. 59-65, , Salamanca, Salamanca, 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
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
BACTERIA
The article appears to contain a poisonous and deleterious substance which may render it injurious to health. Contains
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/9/2012 | 53LC08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 11/9/2012 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of Southeast Imports (DSEI) | |
| 11/9/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 11/9/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 11/9/2012 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 1/28/2003 | 53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING) | 281BACTERIA | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Alcantara Espana Sa's FDA import refusal history?
Alcantara Espana Sa (FEI: 3001621087) has 6 FDA import refusal record(s) in our database, spanning from 1/28/2003 to 11/9/2012.
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. Alcantara Espana Sa's FEI number is 3001621087.
What types of violations has Alcantara Espana Sa received?
Alcantara Espana Sa 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 Alcantara Espana Sa come from?
All FDA import refusal data for Alcantara Espana Sa 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.