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C & C International Ltd.

⚠️ Moderate Risk

FEI: 1000147278 • Dublin 10 • UNITED KINGDOM

FEI

FEI Number

1000147278

📍

Location

Dublin 10

🇬🇧
🏢

Address

Kylemore Park, , Dublin 10, , 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

1
Total Refusals
3
Unique Violations
3/22/2006
Latest Refusal
3/22/2006
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

161×

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.

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).

821×

RX LEGEND

The article appears to be a prescription drug without a prescription drug legend as required by Section 503(b)(4).

Refusal History

DateProductViolationsDivision
3/22/2006
64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID)
16DIRECTIONS
75UNAPPROVED
82RX LEGEND
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is C & C International Ltd.'s FDA import refusal history?

C & C International Ltd. (FEI: 1000147278) has 1 FDA import refusal record(s) in our database, spanning from 3/22/2006 to 3/22/2006.

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. C & C International Ltd.'s FEI number is 1000147278.

What types of violations has C & C International Ltd. received?

C & C International Ltd. 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 C & C International Ltd. come from?

All FDA import refusal data for C & C International 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.