Unilever De Argentina
⚠️ Moderate Risk
FEI: 3000243789 • Ciudad Autonoma Buenos Aires, Buenos Aires • ARGENTINA
FEI Number
3000243789
Location
Ciudad Autonoma Buenos Aires, Buenos Aires
Country
ARGENTINAAddress
Calle Manuel Fraga 1163, , Ciudad Autonoma Buenos Aires, Buenos Aires, 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
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).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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.
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 |
|---|---|---|---|
| 3/19/2010 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/19/2010 | 62WBY99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/16/2009 | 62WBQ17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Florida District Office (FLA-DO) | |
| 10/30/2007 | 53LH04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Unilever De Argentina's FDA import refusal history?
Unilever De Argentina (FEI: 3000243789) has 4 FDA import refusal record(s) in our database, spanning from 10/30/2007 to 3/19/2010.
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. Unilever De Argentina's FEI number is 3000243789.
What types of violations has Unilever De Argentina received?
Unilever De Argentina 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 Unilever De Argentina come from?
All FDA import refusal data for Unilever De Argentina 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.