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Orange Drugs Comapny

⚠️ Moderate Risk

FEI: 3006755325 • Lagos, Lagos • NIGERIA

FEI

FEI Number

3006755325

📍

Location

Lagos, Lagos

🇳🇬

Country

NIGERIA
🏢

Address

Ilupeju, Town Planning St., Lagos, Lagos, Nigeria

Moderate Risk

FDA Import Risk Assessment

44.1
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

4
Total Refusals
1
Unique Violations
6/25/2020
Latest Refusal
4/6/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
3.6×10%
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

754×

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
6/25/2020
62UDY11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD)
75UNAPPROVED
Division of Southeast Imports (DSEI)
6/25/2020
61XDY08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/13/2012
53BY99OTHER BATH PREPARATIONS, N.E.C.
75UNAPPROVED
Southwest Import District Office (SWI-DO)
4/6/2009
64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID)
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Orange Drugs Comapny's FDA import refusal history?

Orange Drugs Comapny (FEI: 3006755325) has 4 FDA import refusal record(s) in our database, spanning from 4/6/2009 to 6/25/2020.

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. Orange Drugs Comapny's FEI number is 3006755325.

What types of violations has Orange Drugs Comapny received?

Orange Drugs Comapny 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 Orange Drugs Comapny come from?

All FDA import refusal data for Orange Drugs Comapny 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.