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I-Med Pharma Inc.

⚠️ Moderate Risk

FEI: 3004956832 • Dollard-Des-Ormeaux, Quebec • CANADA

FEI

FEI Number

3004956832

📍

Location

Dollard-Des-Ormeaux, Quebec

🇨🇦

Country

CANADA
🏢

Address

1601 Saint-Regis St, , Dollard-Des-Ormeaux, Quebec, Canada

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/12/2006
Latest Refusal
12/12/2006
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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).

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
12/12/2006
78MRESOLUTION, SODIUM HYALURONATE
118NOT LISTED
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is I-Med Pharma Inc.'s FDA import refusal history?

I-Med Pharma Inc. (FEI: 3004956832) has 1 FDA import refusal record(s) in our database, spanning from 12/12/2006 to 12/12/2006.

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. I-Med Pharma Inc.'s FEI number is 3004956832.

What types of violations has I-Med Pharma Inc. received?

I-Med Pharma 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 I-Med Pharma Inc. come from?

All FDA import refusal data for I-Med Pharma 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.