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Biodroga Nutraceuticals Inc.

⚠️ Moderate Risk

FEI: 3003157401 • Vaudreuil-Dorion, Quebec • CANADA

FEI

FEI Number

3003157401

📍

Location

Vaudreuil-Dorion, Quebec

🇨🇦

Country

CANADA
🏢

Address

301 Joseph-Carrier St, , Vaudreuil-Dorion, Quebec, Canada

Moderate Risk

FDA Import Risk Assessment

27.2
LowModerateHighCritical

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

Statistics

4
Total Refusals
4
Unique Violations
6/20/2012
Latest Refusal
8/16/2011
Earliest Refusal

Score Breakdown

Violation Severity
38.6×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

2184×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

4734×

LABELING

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

4824×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

3202×

LACKS FIRM

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
6/20/2012
54HYH04FISH OIL (FATS AND LIPID SUBSTANCES)
218LIST INGRE
320LACKS FIRM
473LABELING
482NUTRIT LBL
New Orleans District Office (NOL-DO)
6/20/2012
54HYH04FISH OIL (FATS AND LIPID SUBSTANCES)
218LIST INGRE
320LACKS FIRM
473LABELING
482NUTRIT LBL
New Orleans District Office (NOL-DO)
8/16/2011
54HYL99FATS AND LIPID SUBSTANCES, N.E.C.
218LIST INGRE
473LABELING
482NUTRIT LBL
New Orleans District Office (NOL-DO)
8/16/2011
54HYL04FISH OIL (FATS AND LIPID SUBSTANCES)
218LIST INGRE
473LABELING
482NUTRIT LBL
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Biodroga Nutraceuticals Inc.'s FDA import refusal history?

Biodroga Nutraceuticals Inc. (FEI: 3003157401) has 4 FDA import refusal record(s) in our database, spanning from 8/16/2011 to 6/20/2012.

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. Biodroga Nutraceuticals Inc.'s FEI number is 3003157401.

What types of violations has Biodroga Nutraceuticals Inc. received?

Biodroga Nutraceuticals Inc. has been cited for 4 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 Biodroga Nutraceuticals Inc. come from?

All FDA import refusal data for Biodroga Nutraceuticals 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.