LEO Pharma Ireland
⚠️ Moderate Risk
FEI: 3002807468 • Dublin 12, Co. DUBLIN • IRELAND
FEI Number
3002807468
Location
Dublin 12, Co. DUBLIN
Country
IRELANDAddress
285 Cashel Road, , Dublin 12, Co. DUBLIN, Ireland
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/4/2024 | 64LCJ03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/24/2022 | 56YDA99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/24/2022 | 64LDA03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/18/2002 | 64BCS09BUMETANIDE (DIURETIC) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is LEO Pharma Ireland's FDA import refusal history?
LEO Pharma Ireland (FEI: 3002807468) has 4 FDA import refusal record(s) in our database, spanning from 12/18/2002 to 1/4/2024.
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. LEO Pharma Ireland's FEI number is 3002807468.
What types of violations has LEO Pharma Ireland received?
LEO Pharma Ireland 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 LEO Pharma Ireland come from?
All FDA import refusal data for LEO Pharma Ireland 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.