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Suntrition Inc.

⚠️ Moderate Risk

FEI: 3003625153 • Windsor, Ontario • CANADA

FEI

FEI Number

3003625153

📍

Location

Windsor, Ontario

🇨🇦

Country

CANADA
🏢

Address

2835 Kew Dr Unit 8, , Windsor, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

33.4
LowModerateHighCritical

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

Statistics

9
Total Refusals
7
Unique Violations
12/12/2014
Latest Refusal
5/4/2005
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
37.0×30%
Recency
0.0×20%
Frequency
9.4×10%
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

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.

2183×

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.

23003×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

2492×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

2562×

INCONSPICU

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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

111×

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).

751×

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).

Refusal History

DateProductViolationsDivision
12/12/2014
54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Detroit District Office (DET-DO)
9/20/2010
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2300DIETARYLBL
482NUTRIT LBL
Detroit District Office (DET-DO)
9/20/2010
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2300DIETARYLBL
482NUTRIT LBL
Detroit District Office (DET-DO)
9/20/2010
54FCB99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2300DIETARYLBL
482NUTRIT LBL
Detroit District Office (DET-DO)
6/17/2010
54GCH04SHARK (ANIMAL BY-PRODUCTS AND EXTRACTS)
249FILTHY
Detroit District Office (DET-DO)
6/17/2010
54GCH04SHARK (ANIMAL BY-PRODUCTS AND EXTRACTS)
249FILTHY
Detroit District Office (DET-DO)
3/5/2010
54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
11UNSAFE COL
218LIST INGRE
New York District Office (NYK-DO)
5/4/2005
54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
218LIST INGRE
256INCONSPICU
Cincinnati District Office (CIN-DO)
5/4/2005
54FCA99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
218LIST INGRE
256INCONSPICU
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Suntrition Inc.'s FDA import refusal history?

Suntrition Inc. (FEI: 3003625153) has 9 FDA import refusal record(s) in our database, spanning from 5/4/2005 to 12/12/2014.

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. Suntrition Inc.'s FEI number is 3003625153.

What types of violations has Suntrition Inc. received?

Suntrition Inc. 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 Suntrition Inc. come from?

All FDA import refusal data for Suntrition 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.