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INTERNATIONAL POINT OF CARE

⚠️ Moderate Risk

FEI: 3012458221 • Etobicoke, ON • CANADA

FEI

FEI Number

3012458221

📍

Location

Etobicoke, ON

🇨🇦

Country

CANADA
🏢

Address

135 The West Mall Unit, , Etobicoke, ON, Canada

Moderate Risk

FDA Import Risk Assessment

29.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/1/2023
Latest Refusal
2/1/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
27.1×20%
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).

Refusal History

DateProductViolationsDivision
2/1/2023
74MLOELECTROCARDIOGRAPH, AMBULATORY WITH ANALYSIS ALGORITHM
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is INTERNATIONAL POINT OF CARE's FDA import refusal history?

INTERNATIONAL POINT OF CARE (FEI: 3012458221) has 1 FDA import refusal record(s) in our database, spanning from 2/1/2023 to 2/1/2023.

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. INTERNATIONAL POINT OF CARE's FEI number is 3012458221.

What types of violations has INTERNATIONAL POINT OF CARE received?

INTERNATIONAL POINT OF CARE 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 INTERNATIONAL POINT OF CARE come from?

All FDA import refusal data for INTERNATIONAL POINT OF CARE 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.