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Cmp Advanced Mechanical Ltd

⚠️ Moderate Risk

FEI: 3004634706 • Chateauguay, QC • CANADA

FEI

FEI Number

3004634706

📍

Location

Chateauguay, QC

🇨🇦

Country

CANADA
🏢

Address

1241 Rue Cascades, , Chateauguay, QC, Canada

Moderate Risk

FDA Import Risk Assessment

26.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
12/30/2011
Latest Refusal
12/21/2008
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
6.6×10%
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

1182×

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
12/30/2011
79LRPTRAY, SURGICAL
118NOT LISTED
New Orleans District Office (NOL-DO)
12/21/2008
74DTBELECTRODE, PACEMAKER, PERMANENT
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Cmp Advanced Mechanical Ltd's FDA import refusal history?

Cmp Advanced Mechanical Ltd (FEI: 3004634706) has 2 FDA import refusal record(s) in our database, spanning from 12/21/2008 to 12/30/2011.

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. Cmp Advanced Mechanical Ltd's FEI number is 3004634706.

What types of violations has Cmp Advanced Mechanical Ltd received?

Cmp Advanced Mechanical Ltd has been cited for 1 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 Cmp Advanced Mechanical Ltd come from?

All FDA import refusal data for Cmp Advanced Mechanical 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.