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ALFA TUNDE

✅ Low Risk

FEI: 3012688389 • Ilorin • NIGERIA

FEI

FEI Number

3012688389

📍

Location

Ilorin

🇳🇬

Country

NIGERIA
🏢

Address

Olojo Area, , Ilorin, , Nigeria

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
4
Unique Violations
10/7/2016
Latest Refusal
10/7/2016
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

161×

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.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
10/7/2016
64TBR99IMMUNOSUPPRESS N.E.C.
16DIRECTIONS
333LACKS FIRM
335LACKS N/C
483DRUG NAME
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ALFA TUNDE's FDA import refusal history?

ALFA TUNDE (FEI: 3012688389) has 1 FDA import refusal record(s) in our database, spanning from 10/7/2016 to 10/7/2016.

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. ALFA TUNDE's FEI number is 3012688389.

What types of violations has ALFA TUNDE received?

ALFA TUNDE has been cited for 4 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 ALFA TUNDE come from?

All FDA import refusal data for ALFA TUNDE 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.