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Creaghan Mcconnell Group Ltd.

⚠️ Moderate Risk

FEI: 3010603318 • Burlington, ON • CANADA

FEI

FEI Number

3010603318

📍

Location

Burlington, ON

🇨🇦

Country

CANADA
🏢

Address

442 Brant St, , Burlington, ON, Canada

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/6/2014
Latest Refusal
2/6/2014
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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).

Refusal History

DateProductViolationsDivision
2/6/2014
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Creaghan Mcconnell Group Ltd.'s FDA import refusal history?

Creaghan Mcconnell Group Ltd. (FEI: 3010603318) has 1 FDA import refusal record(s) in our database, spanning from 2/6/2014 to 2/6/2014.

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. Creaghan Mcconnell Group Ltd.'s FEI number is 3010603318.

What types of violations has Creaghan Mcconnell Group Ltd. received?

Creaghan Mcconnell Group 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 Creaghan Mcconnell Group Ltd. come from?

All FDA import refusal data for Creaghan Mcconnell Group 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.