UNIQUE PHARMACEUTICALS
⚠️ High Risk
FEI: 3013702708 • Ogon • NIGERIA
FEI Number
3013702708
Location
Ogon
Country
NIGERIAAddress
Kn 38 Abeokuta Road San, , Ogon, , Nigeria
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/4/2025 | 62LDA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | Division of Southeast Imports (DSEI) | |
| 9/23/2024 | 61HBA03TRIMETHOPRIM (ANTI-BACTERIAL) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/13/2024 | 62LCA50METRONIDAZOLE HYDROCHLORIDE (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | Division of Southeast Imports (DSEI) | |
| 2/13/2024 | 60WDL01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/3/2024 | 62LCA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/7/2023 | 61HCY99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/1/2017 | 62LDA40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is UNIQUE PHARMACEUTICALS's FDA import refusal history?
UNIQUE PHARMACEUTICALS (FEI: 3013702708) has 7 FDA import refusal record(s) in our database, spanning from 9/1/2017 to 3/4/2025.
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. UNIQUE PHARMACEUTICALS's FEI number is 3013702708.
What types of violations has UNIQUE PHARMACEUTICALS received?
UNIQUE PHARMACEUTICALS 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 UNIQUE PHARMACEUTICALS come from?
All FDA import refusal data for UNIQUE PHARMACEUTICALS 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.