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Colgate Palmolive (Uk) Limited

⚠️ Moderate Risk

FEI: 3003496018 • Guildford, Surrey • UNITED KINGDOM

FEI

FEI Number

3003496018

📍

Location

Guildford, Surrey

🇬🇧
🏢

Address

Unit 1b, Guildford Business Park, Guildford, Surrey, United Kingdom

Moderate Risk

FDA Import Risk Assessment

35.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
6/23/2022
Latest Refusal
6/19/2006
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
22.3×30%
Recency
14.1×20%
Frequency
1.9×10%
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

1182×

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).

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
6/23/2022
63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
75UNAPPROVED
Division of Northern Border Imports (DNBI)
6/19/2006
63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
New York District Office (NYK-DO)
6/19/2006
63RBJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Colgate Palmolive (Uk) Limited's FDA import refusal history?

Colgate Palmolive (Uk) Limited (FEI: 3003496018) has 3 FDA import refusal record(s) in our database, spanning from 6/19/2006 to 6/23/2022.

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 (Uk) Limited's FEI number is 3003496018.

What types of violations has Colgate Palmolive (Uk) Limited received?

Colgate Palmolive (Uk) Limited has been cited for 2 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 (Uk) Limited come from?

All FDA import refusal data for Colgate Palmolive (Uk) Limited 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.