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Cosmetics Limited

⚠️ Moderate Risk

FEI: 3003428673 • Harrow, Middlesex • UNITED KINGDOM

FEI

FEI Number

3003428673

📍

Location

Harrow, Middlesex

🇬🇧
🏢

Address

92 Uxbridge Road, WEALD, Harrow, Middlesex, United Kingdom

Moderate Risk

FDA Import Risk Assessment

31.9
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
7/29/2004
Latest Refusal
2/4/2002
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
12.1×10%
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

1183×

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
7/29/2004
63PAO99CHOLINESTERASE REACTIVATOR N.E.C.
118NOT LISTED
75UNAPPROVED
San Francisco District Office (SAN-DO)
2/12/2002
65LBJ11TITANIUM DIOXIDE (PROTECTANT)
118NOT LISTED
San Francisco District Office (SAN-DO)
2/4/2002
53MC01SUNTAN GELS, CREAMS, LIQUIDS (NOT SUNSCREEN) (SUNTAN PREPARATIONS)
118NOT LISTED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Cosmetics Limited's FDA import refusal history?

Cosmetics Limited (FEI: 3003428673) has 3 FDA import refusal record(s) in our database, spanning from 2/4/2002 to 7/29/2004.

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. Cosmetics Limited's FEI number is 3003428673.

What types of violations has Cosmetics Limited received?

Cosmetics 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 Cosmetics Limited come from?

All FDA import refusal data for Cosmetics 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.