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PRAXAIR CANADA INC

⚠️ Moderate Risk

FEI: 3013894422 • Longueuil, Quebec • CANADA

FEI

FEI Number

3013894422

📍

Location

Longueuil, Quebec

🇨🇦

Country

CANADA
🏢

Address

2794 Ch De Chambly, , Longueuil, Quebec, Canada

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
3/29/2018
Latest Refusal
3/29/2018
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

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
3/29/2018
73OBNHUMIDIFIER, RESPIRATORY, MASK (DIRECT PATIENT INTERFACE)
118NOT LISTED
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is PRAXAIR CANADA INC's FDA import refusal history?

PRAXAIR CANADA INC (FEI: 3013894422) has 1 FDA import refusal record(s) in our database, spanning from 3/29/2018 to 3/29/2018.

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. PRAXAIR CANADA INC's FEI number is 3013894422.

What types of violations has PRAXAIR CANADA INC received?

PRAXAIR CANADA INC 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 PRAXAIR CANADA INC come from?

All FDA import refusal data for PRAXAIR CANADA 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.