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Remed Pharma SA/NV

⚠️ Moderate Risk

FEI: 3000190754 • Uccle, Brussels • BELGIUM

FEI

FEI Number

3000190754

📍

Location

Uccle, Brussels

🇧🇪

Country

BELGIUM
🏢

Address

Chaussee d'Alsemberg 995, , Uccle, Brussels, Belgium

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
8/22/2003
Latest Refusal
4/18/2003
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

4771×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

Refusal History

DateProductViolationsDivision
8/22/2003
85HISCONDOM
341REGISTERED
Florida District Office (FLA-DO)
4/18/2003
85HISCONDOM
477HOLES
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Remed Pharma SA/NV's FDA import refusal history?

Remed Pharma SA/NV (FEI: 3000190754) has 2 FDA import refusal record(s) in our database, spanning from 4/18/2003 to 8/22/2003.

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. Remed Pharma SA/NV's FEI number is 3000190754.

What types of violations has Remed Pharma SA/NV received?

Remed Pharma SA/NV 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 Remed Pharma SA/NV come from?

All FDA import refusal data for Remed Pharma SA/NV 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.