Leo Pharma Inc
⚠️ Moderate Risk
FEI: 3004705724 • Thornhill, NEWFOUNDLAND • CANADA
FEI Number
3004705724
Location
Thornhill, NEWFOUNDLAND
Country
CANADAAddress
123 Commerce Valley Dr E, , Thornhill, NEWFOUNDLAND, Canada
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/31/2018 | 56YCL99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/7/2018 | 56YCL99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 8/6/2010 | 62NCO99ANTI-PSORIATIC N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 9/8/2008 | 64LAO03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/10/2008 | 61HDO99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Leo Pharma Inc's FDA import refusal history?
Leo Pharma Inc (FEI: 3004705724) has 5 FDA import refusal record(s) in our database, spanning from 4/10/2008 to 7/31/2018.
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 Inc's FEI number is 3004705724.
What types of violations has Leo Pharma Inc received?
Leo Pharma Inc 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 Pharma Inc come from?
All FDA import refusal data for Leo Pharma 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.