Iovate Health Sciences USA Inc.
⚠️ Moderate Risk
FEI: 3007318863 • Blasdell, NY • UNITED STATES
FEI Number
3007318863
Location
Blasdell, NY
Country
UNITED STATESAddress
3880 Jeffrey Blvd, , Blasdell, NY, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
UNSFDIETLB
The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/29/2009 | 54AIY99VITAMIN, N.E.C. | 2460UNSFDIETLB | New Orleans District Office (NOL-DO) |
| 7/16/2009 | 54ABA90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 2460UNSFDIETLB | New Orleans District Office (NOL-DO) |
| 1/3/2007 | 54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Iovate Health Sciences USA Inc.'s FDA import refusal history?
Iovate Health Sciences USA Inc. (FEI: 3007318863) has 3 FDA import refusal record(s) in our database, spanning from 1/3/2007 to 7/29/2009.
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 USA Inc.'s FEI number is 3007318863.
What types of violations has Iovate Health Sciences USA Inc. received?
Iovate Health Sciences USA Inc. has been cited for 3 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 USA Inc. come from?
All FDA import refusal data for Iovate Health Sciences USA 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.