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Clariant Life Science Molecules (Uk) Ltd

⚠️ Moderate Risk

FEI: 3003135452 • Flintshire • UNITED KINGDOM

FEI

FEI Number

3003135452

📍

Location

Flintshire

🇬🇧
🏢

Address

Prince William Avenuesandycroft Deeside, , Flintshire, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

32.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
6/4/2003
Latest Refusal
12/31/2002
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
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

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

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
6/4/2003
66SBS24ISOSORBIDE DINITRATE (VASODILATOR)
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)
12/31/2002
66SBS24ISOSORBIDE DINITRATE (VASODILATOR)
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Clariant Life Science Molecules (Uk) Ltd's FDA import refusal history?

Clariant Life Science Molecules (Uk) Ltd (FEI: 3003135452) has 2 FDA import refusal record(s) in our database, spanning from 12/31/2002 to 6/4/2003.

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. Clariant Life Science Molecules (Uk) Ltd's FEI number is 3003135452.

What types of violations has Clariant Life Science Molecules (Uk) Ltd received?

Clariant Life Science Molecules (Uk) Ltd 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 Clariant Life Science Molecules (Uk) Ltd come from?

All FDA import refusal data for Clariant Life Science Molecules (Uk) Ltd 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.