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HOMEOCAN LABORATOIRES HOMEOPATHIQUES

⚠️ Moderate Risk

FEI: 3030142587 • Montreal, Quebec • CANADA

FEI

FEI Number

3030142587

📍

Location

Montreal, Quebec

🇨🇦

Country

CANADA
🏢

Address

5655 De Marseille St, , Montreal, Quebec, Canada

Moderate Risk

FDA Import Risk Assessment

34.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
1/5/2024
Latest Refusal
1/5/2024
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
Refusal Volume
11.2×30%
Recency
59.2×20%
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.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

Refusal History

DateProductViolationsDivision
1/5/2024
62UBL99ANTI-TUSSIVE/COLD N.E.C.
118NOT LISTED
3280FRNMFGREG
335LACKS N/C
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is HOMEOCAN LABORATOIRES HOMEOPATHIQUES's FDA import refusal history?

HOMEOCAN LABORATOIRES HOMEOPATHIQUES (FEI: 3030142587) has 1 FDA import refusal record(s) in our database, spanning from 1/5/2024 to 1/5/2024.

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. HOMEOCAN LABORATOIRES HOMEOPATHIQUES's FEI number is 3030142587.

What types of violations has HOMEOCAN LABORATOIRES HOMEOPATHIQUES received?

HOMEOCAN LABORATOIRES HOMEOPATHIQUES has been cited for 3 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 HOMEOCAN LABORATOIRES HOMEOPATHIQUES come from?

All FDA import refusal data for HOMEOCAN LABORATOIRES HOMEOPATHIQUES 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.