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Takaso Rubber Products Sdn. Bhd.

✅ Low Risk

FEI: 3008806819 • Johor • MALAYSIA

FEI

FEI Number

3008806819

📍

Location

Johor

🇲🇾

Country

MALAYSIA
🏢

Address

No. 4 & 5 Lorong Jelawat (2), , Johor, , Malaysia

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
4/29/2011
Latest Refusal
4/29/2011
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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).

Refusal History

DateProductViolationsDivision
4/29/2011
85HISCONDOM
341REGISTERED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Takaso Rubber Products Sdn. Bhd.'s FDA import refusal history?

Takaso Rubber Products Sdn. Bhd. (FEI: 3008806819) has 1 FDA import refusal record(s) in our database, spanning from 4/29/2011 to 4/29/2011.

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. Takaso Rubber Products Sdn. Bhd.'s FEI number is 3008806819.

What types of violations has Takaso Rubber Products Sdn. Bhd. received?

Takaso Rubber Products Sdn. Bhd. 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 Takaso Rubber Products Sdn. Bhd. come from?

All FDA import refusal data for Takaso Rubber Products Sdn. Bhd. 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.