UCB Pharma S.A.
⚠️ High Risk
FEI: 3003909356 • Braine-L'Alleud, Brabant Wallon • BELGIUM
FEI Number
3003909356
Location
Braine-L'Alleud, Brabant Wallon
Country
BELGIUMAddress
Chemin Du Foriest, , Braine-L'Alleud, Brabant Wallon, Belgium
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/2/2025 | 58SCK06CERTOLIZUMAB PEGOL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 54AFY12FOLIC ACID (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2024 | 58SCP06CERTOLIZUMAB PEGOL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/23/2024 | 58SCY06CERTOLIZUMAB PEGOL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/4/2020 | 66VCS99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/4/2019 | 61MCA42LEVETIRACETAM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/11/2019 | 62JIY99ANTI-PARKINSONIAN N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 5/23/2017 | 66YDJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/2/2014 | 61MDA42LEVETIRACETAM (ANTI-CONVULSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/30/2013 | 60LCF34METHOTRIMEPRAZINE (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/30/2013 | 61MCF42LEVETIRACETAM (ANTI-CONVULSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/19/2009 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/27/2008 | 61TQA11MECLIZINE HCL (ANTI-EMETIC/NAUSEANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/28/2004 | 61RCS22MESNA (ANTIDOTE) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is UCB Pharma S.A.'s FDA import refusal history?
UCB Pharma S.A. (FEI: 3003909356) has 14 FDA import refusal record(s) in our database, spanning from 4/28/2004 to 12/2/2025.
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. UCB Pharma S.A.'s FEI number is 3003909356.
What types of violations has UCB Pharma S.A. received?
UCB Pharma S.A. 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 UCB Pharma S.A. come from?
All FDA import refusal data for UCB Pharma S.A. 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.