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Richter Rubber Technology Sdn Bdh

⚠️ Moderate Risk

FEI: 3004063764 • Kuala Ketil, Kedah • MALAYSIA

FEI

FEI Number

3004063764

📍

Location

Kuala Ketil, Kedah

🇲🇾

Country

MALAYSIA
🏢

Address

Plot 209, Kuala Ketil Industrial Estate, , Kuala Ketil, Kedah, Malaysia

Moderate Risk

FDA Import Risk Assessment

32.0
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
4/6/2021
Latest Refusal
1/31/2007
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
2.8×10%
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

4773×

HOLES

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

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).

Refusal History

DateProductViolationsDivision
4/6/2021
85HISCONDOM
341REGISTERED
Division of West Coast Imports (DWCI)
2/7/2007
85HISCONDOM
477HOLES
Los Angeles District Office (LOS-DO)
1/31/2007
85HISCONDOM
477HOLES
Los Angeles District Office (LOS-DO)
1/31/2007
85HISCONDOM
477HOLES
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Richter Rubber Technology Sdn Bdh's FDA import refusal history?

Richter Rubber Technology Sdn Bdh (FEI: 3004063764) has 4 FDA import refusal record(s) in our database, spanning from 1/31/2007 to 4/6/2021.

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. Richter Rubber Technology Sdn Bdh's FEI number is 3004063764.

What types of violations has Richter Rubber Technology Sdn Bdh received?

Richter Rubber Technology Sdn Bdh 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 Richter Rubber Technology Sdn Bdh come from?

All FDA import refusal data for Richter Rubber Technology Sdn Bdh 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.