Horphag Research (Europe) Ltd
⚠️ Moderate Risk
FEI: 3010275290 • Lemesos, Lemesos • CYPRUS
FEI Number
3010275290
Location
Lemesos, Lemesos
Country
CYPRUSAddress
Karaiskaki 38, Kanika Alexander Court, 1st Floor, Office 113 CD, Lemesos, Lemesos, Cyprus
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
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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 |
|---|---|---|---|
| 7/21/2021 | 54ACZ99VITAMIN, N.E.C. | Division of Northeast Imports (DNEI) | |
| 11/20/2018 | 54ACA99VITAMIN, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/13/2018 | 54ACA99VITAMIN, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/7/2017 | 54YCB99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Horphag Research (Europe) Ltd's FDA import refusal history?
Horphag Research (Europe) Ltd (FEI: 3010275290) has 4 FDA import refusal record(s) in our database, spanning from 12/7/2017 to 7/21/2021.
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. Horphag Research (Europe) Ltd's FEI number is 3010275290.
What types of violations has Horphag Research (Europe) Ltd received?
Horphag Research (Europe) Ltd 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 Horphag Research (Europe) Ltd come from?
All FDA import refusal data for Horphag Research (Europe) Ltd 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.