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Iovate Health Sciences

⚠️ Moderate Risk

FEI: 3004517553 • Mississauga, Ontario • CANADA

FEI

FEI Number

3004517553

📍

Location

Mississauga, Ontario

🇨🇦

Country

CANADA
🏢

Address

5100 Spectrum Way, , Mississauga, Ontario, Canada

Moderate Risk

FDA Import Risk Assessment

35.2
LowModerateHighCritical

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

Statistics

7
Total Refusals
6
Unique Violations
11/17/2009
Latest Refusal
5/21/2007
Earliest Refusal

Score Breakdown

Violation Severity
55.8×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
28.1×10%
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

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.

2182×

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.

23002×

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.

2512×

POISONOUS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:

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).

4881×

HEALTH C

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 bears an unauthorized nutrient content/health claim.

Refusal History

DateProductViolationsDivision
11/17/2009
41YGY99DIETARY CONVENTIONAL FOODS, N.E.C.
2300DIETARYLBL
482NUTRIT LBL
488HEALTH C
New York District Office (NYK-DO)
10/20/2009
54YEC99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
251POISONOUS
San Francisco District Office (SAN-DO)
10/20/2009
54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
251POISONOUS
San Francisco District Office (SAN-DO)
3/5/2008
41YYY99DIETARY CONVENTIONAL FOODS, N.E.C.
482NUTRIT LBL
New York District Office (NYK-DO)
3/5/2008
41YYY99DIETARY CONVENTIONAL FOODS, N.E.C.
218LIST INGRE
482NUTRIT LBL
New York District Office (NYK-DO)
5/21/2007
41YYY99DIETARY CONVENTIONAL FOODS, N.E.C.
2300DIETARYLBL
482NUTRIT LBL
New York District Office (NYK-DO)
5/21/2007
41YYY99DIETARY CONVENTIONAL FOODS, N.E.C.
11UNSAFE COL
218LIST INGRE
New York District Office (NYK-DO)

Frequently Asked Questions

What is Iovate Health Sciences's FDA import refusal history?

Iovate Health Sciences (FEI: 3004517553) has 7 FDA import refusal record(s) in our database, spanning from 5/21/2007 to 11/17/2009.

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. Iovate Health Sciences's FEI number is 3004517553.

What types of violations has Iovate Health Sciences received?

Iovate Health Sciences has been cited for 6 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 Iovate Health Sciences come from?

All FDA import refusal data for Iovate Health Sciences 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.