ImportRefusal LogoImportRefusal

Unilever

⚠️ Moderate Risk

FEI: 3004756097 • Durban • SAUDI ARABIA

FEI

FEI Number

3004756097

📍

Location

Durban

🇸🇦
🏢

Address

15 Nollsworth Crescent, , Durban, , Saudi Arabia

Moderate Risk

FDA Import Risk Assessment

29.0
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
4
Unique Violations
7/3/2012
Latest Refusal
4/9/2008
Earliest Refusal

Score Breakdown

Violation Severity
54.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
7.1×10%
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

4752×

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.

1181×

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).

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

751×

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

DateProductViolationsDivision
7/3/2012
53BY99OTHER BATH PREPARATIONS, N.E.C.
475COSMETLBLG
New Orleans District Office (NOL-DO)
7/3/2012
53BY99OTHER BATH PREPARATIONS, N.E.C.
475COSMETLBLG
New Orleans District Office (NOL-DO)
4/9/2008
62NCJ99ANTI-PSORIATIC N.E.C.
118NOT LISTED
483DRUG NAME
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Unilever's FDA import refusal history?

Unilever (FEI: 3004756097) has 3 FDA import refusal record(s) in our database, spanning from 4/9/2008 to 7/3/2012.

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. Unilever's FEI number is 3004756097.

What types of violations has Unilever received?

Unilever 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 come from?

All FDA import refusal data for Unilever 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.