ImportRefusal LogoImportRefusal

Avmor Ltd.

⚠️ Moderate Risk

FEI: 3003101044 • Laval, Quebec • CANADA

FEI

FEI Number

3003101044

📍

Location

Laval, Quebec

🇨🇦

Country

CANADA
🏢

Address

950 Michelin St, , Laval, Quebec, Canada

Moderate Risk

FDA Import Risk Assessment

38.1
LowModerateHighCritical

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

Statistics

8
Total Refusals
7
Unique Violations
6/1/2012
Latest Refusal
1/19/2005
Earliest Refusal

Score Breakdown

Violation Severity
66.2×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
10.9×10%
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

114×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

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).

752×

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).

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

4751×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

Refusal History

DateProductViolationsDivision
6/1/2012
61FAL21CHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC)
118NOT LISTED
75UNAPPROVED
Detroit District Office (DET-DO)
12/29/2011
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Detroit District Office (DET-DO)
3/28/2005
64ABL20TRICLOSAN (DISINFECTANT)
118NOT LISTED
223FALSE
New York District Office (NYK-DO)
3/15/2005
64ABL20TRICLOSAN (DISINFECTANT)
473LABELING
New York District Office (NYK-DO)
3/15/2005
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
11UNSAFE COL
475COSMETLBLG
New York District Office (NYK-DO)
3/15/2005
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
11UNSAFE COL
473LABELING
New York District Office (NYK-DO)
1/19/2005
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
11UNSAFE COL
471CSTIC LBLG
New York District Office (NYK-DO)
1/19/2005
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
11UNSAFE COL
New York District Office (NYK-DO)

Frequently Asked Questions

What is Avmor Ltd.'s FDA import refusal history?

Avmor Ltd. (FEI: 3003101044) has 8 FDA import refusal record(s) in our database, spanning from 1/19/2005 to 6/1/2012.

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. Avmor Ltd.'s FEI number is 3003101044.

What types of violations has Avmor Ltd. received?

Avmor Ltd. has been cited for 7 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 Avmor Ltd. come from?

All FDA import refusal data for Avmor 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.