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Unilever Us,Inc

✅ Low Risk

FEI: 3000210067 • New York, NY • UNITED STATES

FEI

FEI Number

3000210067

📍

Location

New York, NY

🇺🇸
🏢

Address

390 Park Ave Fl 19, , New York, NY, United States

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
4
Unique Violations
6/16/2003
Latest Refusal
4/18/2003
Earliest Refusal

Score Breakdown

Violation Severity
42.5×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

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).

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
6/16/2003
62WBR17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT)
118NOT LISTED
335LACKS N/C
New York District Office (NYK-DO)
4/18/2003
63RAJ06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
336INCONSPICU
473LABELING
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Unilever Us,Inc's FDA import refusal history?

Unilever Us,Inc (FEI: 3000210067) has 2 FDA import refusal record(s) in our database, spanning from 4/18/2003 to 6/16/2003.

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 Us,Inc's FEI number is 3000210067.

What types of violations has Unilever Us,Inc received?

Unilever Us,Inc 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 Us,Inc come from?

All FDA import refusal data for Unilever Us,Inc 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.