Leo Pharma A/S
⚠️ High Risk
FEI: 3002807496 • Ballerup • DENMARK
FEI Number
3002807496
Location
Ballerup
Country
DENMARKAddress
Industriparken 55, , Ballerup, , Denmark
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).
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).
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
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.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/8/2024 | 56YDL99ANTIBIOTIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/16/2018 | 64TCJ08TACROLIMUS (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/6/2016 | 61LRK22ANTI-COAGULANT HEPARIN SOL | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 11/13/2014 | 61LDY35TINZAPARIN SODIUM (ANTI-COAGULANT) | 27DRUG GMPS | Cincinnati District Office (CIN-DO) |
| 7/10/2012 | 61LIS22ANTI-COAGULANT HEPARIN SOL | 186INSANITARY | New Orleans District Office (NOL-DO) |
| 2/21/2012 | 56YBO99ANTIBIOTIC N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/5/2011 | 61HSY99ANTI-BACTERIAL, N.E.C. | New Orleans District Office (NOL-DO) | |
| 3/10/2011 | 61LDK35TINZAPARIN SODIUM (ANTI-COAGULANT) | 186INSANITARY | New York District Office (NYK-DO) |
| 9/14/2010 | 62NDO04CALCIPOTRIENE (ANTI-PSORIATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/2/2009 | 64BDA09BUMETANIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/27/2009 | 56YCO99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/16/2008 | 61WCJ34CARBOL-FUCHSIN (SOLUTION) (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/13/2007 | 65JIB21MEDROXYPROGESTERONE ACETATE (PROGESTIN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/13/2005 | 62NDJ99ANTI-PSORIATIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/13/2005 | 62NDJ99ANTI-PSORIATIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/23/2005 | 66VCO99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/30/2004 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/25/2004 | 61HCJ99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Leo Pharma A/S's FDA import refusal history?
Leo Pharma A/S (FEI: 3002807496) has 18 FDA import refusal record(s) in our database, spanning from 2/25/2004 to 10/8/2024.
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 A/S's FEI number is 3002807496.
What types of violations has Leo Pharma A/S received?
Leo Pharma A/S has been cited for 5 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 A/S come from?
All FDA import refusal data for Leo Pharma A/S 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.