Leo'S N.V./Sa
⚠️ Moderate Risk
FEI: 3004115018 • Aartselaar, Antwerp • BELGIUM
FEI Number
3004115018
Location
Aartselaar, Antwerp
Country
BELGIUMAddress
Industrie Weg 9, , Aartselaar, Antwerp, Belgium
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/18/2003 | 61WCA45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/18/2003 | 62FCQ53MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/18/2003 | 60LCA99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Leo'S N.V./Sa's FDA import refusal history?
Leo'S N.V./Sa (FEI: 3004115018) has 3 FDA import refusal record(s) in our database, spanning from 9/18/2003 to 9/18/2003.
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. Leo'S N.V./Sa's FEI number is 3004115018.
What types of violations has Leo'S N.V./Sa received?
Leo'S N.V./Sa has been cited for 2 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 Leo'S N.V./Sa come from?
All FDA import refusal data for Leo'S N.V./Sa 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.