Walzen Suisse S A
⚠️ Moderate Risk
FEI: 3005722777 • General Rodriguez • ARGENTINA
FEI Number
3005722777
Location
General Rodriguez
Country
ARGENTINAAddress
Caratini Esq Fournier, , General Rodriguez, , 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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 1/7/2012 | 53JD04FEMININE DEODORANTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 1/7/2012 | 53JD04FEMININE DEODORANTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Walzen Suisse S A's FDA import refusal history?
Walzen Suisse S A (FEI: 3005722777) has 3 FDA import refusal record(s) in our database, spanning from 1/7/2012 to 1/7/2012.
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. Walzen Suisse S A's FEI number is 3005722777.
What types of violations has Walzen Suisse S A received?
Walzen Suisse 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 Walzen Suisse S A come from?
All FDA import refusal data for Walzen Suisse 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.