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Colgate Palmolive

⚠️ Moderate Risk

FEI: 3008337265 • Warsaw • POLAND

FEI

FEI Number

3008337265

📍

Location

Warsaw

🇵🇱

Country

POLAND
🏢

Address

Wybrzeze Gydnski 6d, , Warsaw, , Poland

Moderate Risk

FDA Import Risk Assessment

42.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
10/31/2025
Latest Refusal
10/31/2025
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
Refusal Volume
11.2×30%
Recency
96.1×20%
Frequency
10.0×10%
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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

731×

DRUG COLOR

The article appears to be a color additive the intended use of which is for the purpose of coloring only, and its packaging and labeling do not conform to regulations issued under section 721.

Refusal History

DateProductViolationsDivision
10/31/2025
53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
118NOT LISTED
3280FRNMFGREG
73DRUG COLOR
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Colgate Palmolive's FDA import refusal history?

Colgate Palmolive (FEI: 3008337265) has 1 FDA import refusal record(s) in our database, spanning from 10/31/2025 to 10/31/2025.

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. Colgate Palmolive's FEI number is 3008337265.

What types of violations has Colgate Palmolive received?

Colgate Palmolive has been cited for 3 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 Colgate Palmolive come from?

All FDA import refusal data for Colgate Palmolive 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.