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HOPITAL DE LA RIVE

⚠️ High Risk

FEI: 3030842281 • Kinshasa • DEMOCRATIC REPUBLIC OF THE CONGO

FEI

FEI Number

3030842281

📍

Location

Kinshasa

🏢

Address

Tourisme Avenue 1, , Kinshasa, , Democratic Republic of the Congo

High Risk

FDA Import Risk Assessment

57.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
8/8/2024
Latest Refusal
8/8/2024
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
71.5×20%
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

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
8/8/2024
61FCA57CLOFAZIMINE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
8/8/2024
65GCA01METHOXSALEN (PIGMENTATION AGENT)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is HOPITAL DE LA RIVE's FDA import refusal history?

HOPITAL DE LA RIVE (FEI: 3030842281) has 2 FDA import refusal record(s) in our database, spanning from 8/8/2024 to 8/8/2024.

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. HOPITAL DE LA RIVE's FEI number is 3030842281.

What types of violations has HOPITAL DE LA RIVE received?

HOPITAL DE LA RIVE 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 HOPITAL DE LA RIVE come from?

All FDA import refusal data for HOPITAL DE LA RIVE 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.