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LABORIE MEDICAL TECHNOLOGIES, CANADA ULC

⚠️ Moderate Risk

FEI: 3001438491 • Mississauga, Ontario • CANADA

FEI

FEI Number

3001438491

📍

Location

Mississauga, Ontario

🇨🇦

Country

CANADA
🏢

Address

6415 Northwest Dr Unit 11, , Mississauga, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

25.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
12/7/2012
Latest Refusal
10/30/2006
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
3.3×10%
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

3412×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

24801×

RXPERSONAL

The article appears to be a device which requires a prescription from your doctor.

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
12/7/2012
78FAPCYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE
2480RXPERSONAL
341REGISTERED
Cincinnati District Office (CIN-DO)
10/30/2006
78NHVSYSTEM, WATER PURIFICATION, GENERAL MEDICAL USE
341REGISTERED
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LABORIE MEDICAL TECHNOLOGIES, CANADA ULC's FDA import refusal history?

LABORIE MEDICAL TECHNOLOGIES, CANADA ULC (FEI: 3001438491) has 2 FDA import refusal record(s) in our database, spanning from 10/30/2006 to 12/7/2012.

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. LABORIE MEDICAL TECHNOLOGIES, CANADA ULC's FEI number is 3001438491.

What types of violations has LABORIE MEDICAL TECHNOLOGIES, CANADA ULC received?

LABORIE MEDICAL TECHNOLOGIES, CANADA ULC 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 LABORIE MEDICAL TECHNOLOGIES, CANADA ULC come from?

All FDA import refusal data for LABORIE MEDICAL TECHNOLOGIES, CANADA ULC 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.