ImportRefusal LogoImportRefusal

Unilever Brasil Ltda

⚠️ Moderate Risk

FEI: 3003717612 • Vinhedo, Sao Paulo • BRAZIL

FEI

FEI Number

3003717612

📍

Location

Vinhedo, Sao Paulo

🇧🇷

Country

BRAZIL
🏢

Address

Avenida das Industrias 315, , Vinhedo, Sao Paulo, Brazil

Moderate Risk

FDA Import Risk Assessment

41.1
LowModerateHighCritical

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

Statistics

22
Total Refusals
4
Unique Violations
8/1/2012
Latest Refusal
5/19/2010
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
50.4×30%
Recency
0.0×20%
Frequency
99.8×10%
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

47119×

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.

4723×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

4832×

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.

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).

Refusal History

DateProductViolationsDivision
8/1/2012
63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
472NO ENGLISH
Chicago District Office (CHI-DO)
5/19/2010
61HBL05ZINC PYRITHIONE (ANTI-BACTERIAL)
472NO ENGLISH
483DRUG NAME
New York District Office (NYK-DO)
5/19/2010
66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
472NO ENGLISH
483DRUG NAME
New York District Office (NYK-DO)
5/19/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
5/19/2010
53FD04HAIR SHAMPOOS (COLORING) (HAIR COLORING PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)

Frequently Asked Questions

What is Unilever Brasil Ltda's FDA import refusal history?

Unilever Brasil Ltda (FEI: 3003717612) has 22 FDA import refusal record(s) in our database, spanning from 5/19/2010 to 8/1/2012.

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 Brasil Ltda's FEI number is 3003717612.

What types of violations has Unilever Brasil Ltda received?

Unilever Brasil Ltda 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 Brasil Ltda come from?

All FDA import refusal data for Unilever Brasil Ltda 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.