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GENERIX GLOBAL LTD

⚠️ High Risk

FEI: 3030689922 • Benin City, Edo • NIGERIA

FEI

FEI Number

3030689922

📍

Location

Benin City, Edo

🇳🇬

Country

NIGERIA
🏢

Address

12 James Watt Rd., , Benin City, Edo, Nigeria

High Risk

FDA Import Risk Assessment

53.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
5/22/2024
Latest Refusal
5/22/2024
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
66.8×20%
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

751×

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

DateProductViolationsDivision
5/22/2024
62JCY12CABERGOLINE (ANTI-PARKINSONIAN)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GENERIX GLOBAL LTD's FDA import refusal history?

GENERIX GLOBAL LTD (FEI: 3030689922) has 1 FDA import refusal record(s) in our database, spanning from 5/22/2024 to 5/22/2024.

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. GENERIX GLOBAL LTD's FEI number is 3030689922.

What types of violations has GENERIX GLOBAL LTD received?

GENERIX GLOBAL 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 GENERIX GLOBAL LTD come from?

All FDA import refusal data for GENERIX GLOBAL 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.