H. Lundbeck A/S
⚠️ High Risk
FEI: 3002807185 • Valby • 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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/17/2025 | 61NCA83ESCITALOPRAM OXALATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/12/2025 | 61NDY83ESCITALOPRAM OXALATE | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 9/24/2025 | 61NDA83ESCITALOPRAM OXALATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/19/2025 | 61NCC99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/28/2023 | 61NCY83ESCITALOPRAM OXALATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2021 | 66NCA99TRANQUILIZER (ANTI-PSYCHOTIC) - PART II N.E.C. | Division of Northern Border Imports (DNBI) | |
| 7/13/2020 | 61NCY99ANTI-DEPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/24/2018 | 63XCB83MANNITOL (DIAGNOSTIC AID) (DRUGS) | Division of Southeast Imports (DSEI) | |
| 5/25/2016 | 62JAA13DONEPEZIL HCL (ANTI-PARKINSONIAN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/4/2016 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/4/2016 | 62JDB13DONEPEZIL HCL (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/28/2015 | 61NCA83ESCITALOPRAM OXALATE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/22/2015 | 61NCA83ESCITALOPRAM OXALATE | Florida District Office (FLA-DO) | |
| 12/20/2008 | 61NDB83ESCITALOPRAM OXALATE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/23/2006 | 60LNY99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/31/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 65ADN03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/24/2004 | 63XCA99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/24/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/4/2004 | 65ACP99MEMORY ADJUVANT, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/30/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/30/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/30/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/30/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/30/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/30/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/30/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/30/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/30/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/30/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/29/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/29/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/29/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/29/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/29/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/29/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/29/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/29/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/29/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/29/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/29/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/6/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/6/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/12/2003 | 62CDA99ANTI-HYPERTENSIVE N.E.C. | 342PERSONALRX | New York District Office (NYK-DO) |
| 9/21/2003 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/4/2002 | 66VCL99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is H. Lundbeck A/S's FDA import refusal history?
H. Lundbeck A/S (FEI: 3002807185) has 46 FDA import refusal record(s) in our database, spanning from 2/4/2002 to 11/17/2025.
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. H. Lundbeck A/S's FEI number is 3002807185.
What types of violations has H. Lundbeck A/S received?
H. Lundbeck 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 H. Lundbeck A/S come from?
All FDA import refusal data for H. Lundbeck 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.