S M Enterprises

⚠️ Moderate Risk

FEI: 3003436355 • Oakville, Ontario • CANADA

FEI

FEI Number

3003436355

📍

Location

Oakville, Ontario

🇨🇦

Country

CANADA

🏢

Address

2965 Bristol Cir, , Oakville, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

29.2

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/29/2021

Latest Refusal

11/13/2017

Earliest Refusal

Score Breakdown

Violation Severity

45.4×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

16.5×10%

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

2745×

COLOR LBLG

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

3215×

LACKS N/C

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)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

112×

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).

641×

YELLOW #5

The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.

Refusal History

Date	Product	Violations	Division
6/29/2021	33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)	274COLOR LBLG 321LACKS N/C	Division of Northern Border Imports (DNBI)
6/29/2021	33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)	274COLOR LBLG 321LACKS N/C	Division of Northern Border Imports (DNBI)
6/29/2021	33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)	274COLOR LBLG 321LACKS N/C	Division of Northern Border Imports (DNBI)
6/29/2021	33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)	274COLOR LBLG 321LACKS N/C	Division of Northern Border Imports (DNBI)
8/28/2019	33LGH07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)	11UNSAFE COL	Division of Northern Border Imports (DNBI)
11/13/2017	33EYT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)	11UNSAFE COL 274COLOR LBLG 321LACKS N/C 64YELLOW #5	Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is S M Enterprises's FDA import refusal history?

S M Enterprises (FEI: 3003436355) has 6 FDA import refusal record(s) in our database, spanning from 11/13/2017 to 6/29/2021.

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. S M Enterprises's FEI number is 3003436355.

What types of violations has S M Enterprises received?

S M Enterprises 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 S M Enterprises come from?

All FDA import refusal data for S M Enterprises 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.