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LINEN PLUS INC.

⚠️ Moderate Risk

FEI: 3029243868 • Edmonton, Alberta • CANADA

FEI

FEI Number

3029243868

📍

Location

Edmonton, Alberta

🇨🇦

Country

CANADA
🏢

Address

9730 47 Ave Nw, , Edmonton, Alberta, Canada

Moderate Risk

FDA Import Risk Assessment

40.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
2/3/2025
Latest Refusal
1/7/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
66.0×20%
Frequency
20.0×10%
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

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).

32802×

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
2/3/2025
65RDT17RINGER'S INJECTION, LACTATED (REPLENISHER)
118NOT LISTED
3280FRNMFGREG
Division of West Coast Imports (DWCI)
1/7/2025
62RDK03HYCANTHONE (ANTI-SCHISTOSOMAL)
118NOT LISTED
3280FRNMFGREG
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is LINEN PLUS INC.'s FDA import refusal history?

LINEN PLUS INC. (FEI: 3029243868) has 2 FDA import refusal record(s) in our database, spanning from 1/7/2025 to 2/3/2025.

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. LINEN PLUS INC.'s FEI number is 3029243868.

What types of violations has LINEN PLUS INC. received?

LINEN PLUS 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 LINEN PLUS INC. come from?

All FDA import refusal data for LINEN PLUS 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.