FIDSON HEALTHCARE PLC
⚠️ High Risk
FEI: 3019984575 • Lagos, Lagos • NIGERIA
FEI Number
3019984575
Location
Lagos, Lagos
Country
NIGERIAAddress
268 Ikorodu Rd St., , Lagos, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/2/2025 | 61FAA55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | Division of Northeast Imports (DNEI) | |
| 5/22/2025 | 54KDY13GLUCOSAMINE SULFATE (HERBAL AND BOTANICALS, NOT TEAS II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/14/2022 | 64NDY04FERROUS FUMARATE (HEMATINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is FIDSON HEALTHCARE PLC's FDA import refusal history?
FIDSON HEALTHCARE PLC (FEI: 3019984575) has 3 FDA import refusal record(s) in our database, spanning from 11/14/2022 to 9/2/2025.
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. FIDSON HEALTHCARE PLC's FEI number is 3019984575.
What types of violations has FIDSON HEALTHCARE PLC received?
FIDSON HEALTHCARE PLC 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 FIDSON HEALTHCARE PLC come from?
All FDA import refusal data for FIDSON HEALTHCARE 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.