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MEDCANCARE CO LTD

⚠️ Moderate Risk

FEI: 3021291365 • King City, Ontario • CANADA

FEI

FEI Number

3021291365

📍

Location

King City, Ontario

🇨🇦

Country

CANADA
🏢

Address

58 Langdon Dr, , King City, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

26.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
3/1/2022
Latest Refusal
3/1/2022
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
8.7×20%
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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
3/1/2022
80OPAPOWDER-FREE SYNTHETIC/NON-LATEX SURGEON'S GLOVES
118NOT LISTED
3280FRNMFGREG
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is MEDCANCARE CO LTD's FDA import refusal history?

MEDCANCARE CO LTD (FEI: 3021291365) has 1 FDA import refusal record(s) in our database, spanning from 3/1/2022 to 3/1/2022.

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. MEDCANCARE CO LTD's FEI number is 3021291365.

What types of violations has MEDCANCARE CO LTD received?

MEDCANCARE CO LTD 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 MEDCANCARE CO LTD come from?

All FDA import refusal data for MEDCANCARE CO 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.