Neimeth International Pharm., PLC
⚠️ High Risk
FEI: 3003869529 • Oregun, Lagos • NIGERIA
FEI Number
3003869529
Location
Oregun, Lagos
Country
NIGERIAAddress
Plot 16, Akanni Doherty Layout, , Oregun, Lagos, 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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/3/2025 | 55QG45PHENOL (PHARMACEUTIC NECESSITY - PRESERVATIVE) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/6/2025 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/27/2024 | 62HDL99ANTI-MICROBIAL N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/25/2021 | 60ZCY32PYRANTEL PAMOATE (ANTIPARASITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/6/2014 | 64AAN99DISINFECTANT N.E.C. | Division of Northeast Imports (DNEI) | |
| 9/21/2005 | 54ACL90MULTIPLE VITAMINS (MVI-12 VITAMIN COMBO) (VITAMIN) | 473LABELING | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Neimeth International Pharm., PLC's FDA import refusal history?
Neimeth International Pharm., PLC (FEI: 3003869529) has 6 FDA import refusal record(s) in our database, spanning from 9/21/2005 to 12/3/2025.
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. Neimeth International Pharm., PLC's FEI number is 3003869529.
What types of violations has Neimeth International Pharm., PLC received?
Neimeth International Pharm., PLC 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 Neimeth International Pharm., PLC come from?
All FDA import refusal data for Neimeth International Pharm., PLC 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.