ADPHARM PHARMACEUTICAL LTD
🚨 Critical Risk
FEI: 3020055164 • Lagos • NIGERIA
Critical Risk
FDA Import Risk Assessment
This firm has an extensive history of FDA import refusals with severe 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/20/2024 | 61ECA08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 60LCA50PHENACETIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 64HCL01BROMHEXINE HCL (EXPECTORANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 64HCL02GUAIFENESIN (EXPECTORANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 62UDL11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 61GCE80MEROPENEM (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 60ZCA02ALBENDAZOLE (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 60ZCA32PYRANTEL PAMOATE (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 62CCA38METHYLDOPA (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 60XCA17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2024 | 61VDY01SIMETHICONE (ANTI-FLATULENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2024 | 60ZDL32PYRANTEL PAMOATE (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2024 | 61EDL08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2024 | 54YGY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2024 | 61WDY41ZINC UNDECYLENATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2024 | 54HGY05OMEGA-3 (FATS AND LIPID SUBSTANCES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2024 | 54HGY05OMEGA-3 (FATS AND LIPID SUBSTANCES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2024 | 54YGL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2024 | 60LDY99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2024 | 60WDY31PYRANTEL PAMOATE (ANTHELMINTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/7/2024 | 60LCY99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ADPHARM PHARMACEUTICAL LTD's FDA import refusal history?
ADPHARM PHARMACEUTICAL LTD (FEI: 3020055164) has 23 FDA import refusal record(s) in our database, spanning from 5/7/2024 to 9/20/2024.
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. ADPHARM PHARMACEUTICAL LTD's FEI number is 3020055164.
What types of violations has ADPHARM PHARMACEUTICAL LTD received?
ADPHARM PHARMACEUTICAL LTD has been cited for 1 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 ADPHARM PHARMACEUTICAL LTD come from?
All FDA import refusal data for ADPHARM PHARMACEUTICAL LTD 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.