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Juissance Melene

⚠️ Moderate Risk

FEI: 3007507742 • Port-Au-Prince, ouest • HAITI

FEI

FEI Number

3007507742

📍

Location

Port-Au-Prince, ouest

🇭🇹

Country

HAITI
🏢

Address

Rue Boirron Canal # 77 Rte Frere, , Port-Au-Prince, ouest, Haiti

Moderate Risk

FDA Import Risk Assessment

33.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
5/11/2009
Latest Refusal
5/11/2009
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

30002×

N-RX INACT

The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.

752×

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
5/11/2009
63VBJ02HYDROQUINONE (DEPIGMENTOR)
3000N-RX INACT
75UNAPPROVED
Florida District Office (FLA-DO)
5/11/2009
63VBY02HYDROQUINONE (DEPIGMENTOR)
3000N-RX INACT
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Juissance Melene's FDA import refusal history?

Juissance Melene (FEI: 3007507742) has 2 FDA import refusal record(s) in our database, spanning from 5/11/2009 to 5/11/2009.

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. Juissance Melene's FEI number is 3007507742.

What types of violations has Juissance Melene received?

Juissance Melene 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 Juissance Melene come from?

All FDA import refusal data for Juissance Melene 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.