SHALINA HEALTHCARE NIGERIA LTD
⚠️ Moderate Risk
FEI: 3036197157 • Lagos • NIGERIA
FEI Number
3036197157
Location
Lagos
Country
NIGERIAAddress
Block 3b Westerner Industrial Avenie, , Lagos, , Nigeria
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
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).
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
Frequently Asked Questions
What is SHALINA HEALTHCARE NIGERIA LTD's FDA import refusal history?
SHALINA HEALTHCARE NIGERIA LTD (FEI: 3036197157) has 1 FDA import refusal record(s) in our database, spanning from 4/17/2025 to 4/17/2025.
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. SHALINA HEALTHCARE NIGERIA LTD's FEI number is 3036197157.
What types of violations has SHALINA HEALTHCARE NIGERIA LTD received?
SHALINA HEALTHCARE NIGERIA LTD 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 SHALINA HEALTHCARE NIGERIA LTD come from?
All FDA import refusal data for SHALINA HEALTHCARE NIGERIA 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.