2119835 ONTARIO INC

⚠️ High Risk

FEI: 3016494770 • Concord, Ontario • CANADA

FEI

FEI Number

3016494770

📍

Location

Concord, Ontario

🇨🇦

Country

CANADA

🏢

Address

400 Spinnaker Way Unit 15, , Concord, Ontario, Canada

High Risk

FDA Import Risk Assessment

59.0

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

6/27/2024

Latest Refusal

9/22/2023

Earliest Refusal

Score Breakdown

Violation Severity

54.7×40%

Refusal Volume

44.6×30%

Recency

68.8×20%

Frequency

100.0×10%

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

Violation Summary

2187×

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.

2385×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

4823×

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.

2742×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

Refusal History

Date	Product	Violations	Division
6/27/2024	54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	482NUTRIT LBL	Division of Northern Border Imports (DNBI)
6/27/2024	54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	482NUTRIT LBL	Division of Northern Border Imports (DNBI)
6/27/2024	54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	482NUTRIT LBL	Division of Northern Border Imports (DNBI)
6/27/2024	54YCR11WHEY PROTEIN POWDER (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)	218LIST INGRE 274COLOR LBLG	Division of Northern Border Imports (DNBI)
6/27/2024	54YCR11WHEY PROTEIN POWDER (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)	218LIST INGRE 274COLOR LBLG	Division of Northern Border Imports (DNBI)
6/27/2024	54YCR11WHEY PROTEIN POWDER (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)	218LIST INGRE	Division of Northern Border Imports (DNBI)
6/27/2024	54YCR11WHEY PROTEIN POWDER (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)	218LIST INGRE	Division of Northern Border Imports (DNBI)
6/27/2024	54YCR11WHEY PROTEIN POWDER (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)	218LIST INGRE	Division of Northern Border Imports (DNBI)
6/27/2024	54YCR11WHEY PROTEIN POWDER (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)	218LIST INGRE	Division of Northern Border Imports (DNBI)
6/27/2024	54YCR11WHEY PROTEIN POWDER (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.)	218LIST INGRE	Division of Northern Border Imports (DNBI)
9/22/2023	09CCT34WHEY PROTEIN CONCENTRATE	238UNSAFE ADD	Division of Northern Border Imports (DNBI)
9/22/2023	09CCT34WHEY PROTEIN CONCENTRATE	238UNSAFE ADD	Division of Northern Border Imports (DNBI)
9/22/2023	18YCT99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.	238UNSAFE ADD	Division of Northern Border Imports (DNBI)
9/22/2023	18YCT99VEGETABLE PROTEIN PRODUCTS NOT ELSEWHERE MENTIONED, N.E.C.	238UNSAFE ADD	Division of Northern Border Imports (DNBI)
9/22/2023	09CCT34WHEY PROTEIN CONCENTRATE	238UNSAFE ADD	Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is 2119835 ONTARIO INC's FDA import refusal history?

2119835 ONTARIO INC (FEI: 3016494770) has 15 FDA import refusal record(s) in our database, spanning from 9/22/2023 to 6/27/2024.

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. 2119835 ONTARIO INC's FEI number is 3016494770.

What types of violations has 2119835 ONTARIO INC received?

2119835 ONTARIO 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 2119835 ONTARIO INC come from?

All FDA import refusal data for 2119835 ONTARIO 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.