Amalgame Luxe, LTD
⚠️ High Risk
FEI: 3021695092 • Mykolaiv, Mykolaivska • UKRAINE
FEI Number
3021695092
Location
Mykolaiv, Mykolaivska
Country
UKRAINEAddress
Of. 109, Vul. Hromadyanska 119, Mykolaiv, Mykolaivska, Ukraine
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/13/2024 | 61WAY28SELENIUM SULFIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Amalgame Luxe, LTD's FDA import refusal history?
Amalgame Luxe, LTD (FEI: 3021695092) has 1 FDA import refusal record(s) in our database, spanning from 8/13/2024 to 8/13/2024.
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. Amalgame Luxe, LTD's FEI number is 3021695092.
What types of violations has Amalgame Luxe, LTD received?
Amalgame Luxe, LTD 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 Amalgame Luxe, LTD come from?
All FDA import refusal data for Amalgame Luxe, 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.