Xerion S.A.
⚠️ Moderate Risk
FEI: 3007503881 • Capital Federal • ARGENTINA
FEI Number
3007503881
Location
Capital Federal
Country
ARGENTINAAddress
Riodela Plata 9334, , Capital Federal, , Argentina
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
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/13/2011 | 53LC02DEPILATORIES (SKIN CARE PREPARATIONS) | 223FALSE | New Orleans District Office (NOL-DO) |
| 8/12/2010 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 8/12/2010 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 8/12/2010 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 8/11/2010 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Xerion S.A.'s FDA import refusal history?
Xerion S.A. (FEI: 3007503881) has 5 FDA import refusal record(s) in our database, spanning from 8/11/2010 to 12/13/2011.
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. Xerion S.A.'s FEI number is 3007503881.
What types of violations has Xerion S.A. received?
Xerion S.A. 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 Xerion S.A. come from?
All FDA import refusal data for Xerion S.A. 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.