Iovate Health Sciences USA Inc.
⚠️ Moderate Risk
FEI: 3009165761 • Wilmington, DE • UNITED STATES
FEI Number
3009165761
Location
Wilmington, DE
Country
UNITED STATESAddress
1105 N Market St Ste 1330, , Wilmington, DE, 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/23/2012 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 218LIST INGRE | Baltimore District Office (BLT-DO) |
| 10/23/2012 | 54YCZ99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 218LIST INGRE | Baltimore District Office (BLT-DO) |
| 10/23/2012 | 54YCZ99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 218LIST INGRE | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Iovate Health Sciences USA Inc.'s FDA import refusal history?
Iovate Health Sciences USA Inc. (FEI: 3009165761) has 3 FDA import refusal record(s) in our database, spanning from 10/23/2012 to 10/23/2012.
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 3009165761.
What types of violations has Iovate Health Sciences USA Inc. received?
Iovate Health Sciences USA Inc. has been cited for 1 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.