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The Canadian Distribution Center

⚠️ Moderate Risk

FEI: 3005141923 • Brantford, Ontario • CANADA

FEI

FEI Number

3005141923

📍

Location

Brantford, Ontario

🇨🇦

Country

CANADA
🏢

Address

59 Fen Ridge Crt, , Brantford, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

9
Total Refusals
4
Unique Violations
2/8/2012
Latest Refusal
2/8/2012
Earliest Refusal

Score Breakdown

Violation Severity
44.0×40%
Refusal Volume
37.0×30%
Recency
0.0×20%
Frequency
90.0×10%
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

4716×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

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).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
2/8/2012
61HAY05ZINC PYRITHIONE (ANTI-BACTERIAL)
473LABELING
New York District Office (NYK-DO)
2/8/2012
61HAY05ZINC PYRITHIONE (ANTI-BACTERIAL)
473LABELING
New York District Office (NYK-DO)
2/8/2012
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
2/8/2012
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
2/8/2012
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
2/8/2012
53EA99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
471CSTIC LBLG
New York District Office (NYK-DO)
2/8/2012
53EA02HAIR SPRAYS (AEROSOL FIXATIVES) (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
New York District Office (NYK-DO)
2/8/2012
53KA05SHAVING CREAM (AEROSOL, BRUSHLESS, LATHER) (SHAVING PREPARATIONS)
471CSTIC LBLG
New York District Office (NYK-DO)
2/8/2012
85HEBTAMPON, MENSTRUAL, UNSCENTED
118NOT LISTED
508NO 510(K)
New York District Office (NYK-DO)

Frequently Asked Questions

What is The Canadian Distribution Center's FDA import refusal history?

The Canadian Distribution Center (FEI: 3005141923) has 9 FDA import refusal record(s) in our database, spanning from 2/8/2012 to 2/8/2012.

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. The Canadian Distribution Center's FEI number is 3005141923.

What types of violations has The Canadian Distribution Center received?

The Canadian Distribution Center has been cited for 4 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 The Canadian Distribution Center come from?

All FDA import refusal data for The Canadian Distribution Center 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.