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CCE Canada Commercial Exchange Inc

⚠️ Moderate Risk

FEI: 3003412859 • Mississauga, Ontario • CANADA

FEI

FEI Number

3003412859

📍

Location

Mississauga, Ontario

🇨🇦

Country

CANADA
🏢

Address

2735 Matheson Blvd E Unit 3, , Mississauga, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

30.1
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
1/26/2007
Latest Refusal
6/17/2004
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
7.7×10%
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

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).

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
1/26/2007
85LXEFETAL DOPPLER ULTRASOUND
118NOT LISTED
476NO REGISTR
New York District Office (NYK-DO)
6/17/2004
90LWNDEVICE, MEDICAL RADIOGRAPHIC PERSONAL MONITORING
47NON STD
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is CCE Canada Commercial Exchange Inc's FDA import refusal history?

CCE Canada Commercial Exchange Inc (FEI: 3003412859) has 2 FDA import refusal record(s) in our database, spanning from 6/17/2004 to 1/26/2007.

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. CCE Canada Commercial Exchange Inc's FEI number is 3003412859.

What types of violations has CCE Canada Commercial Exchange Inc received?

CCE Canada Commercial Exchange Inc 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 CCE Canada Commercial Exchange Inc come from?

All FDA import refusal data for CCE Canada Commercial Exchange Inc 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.