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Harvik Rubber Industries Dsn Bhd

⚠️ Moderate Risk

FEI: 3009310029 • Perai, Pulau Pinang • MALAYSIA

FEI

FEI Number

3009310029

📍

Location

Perai, Pulau Pinang

🇲🇾

Country

MALAYSIA
🏢

Address

1414 Lorong Perusahaan Maju, , Perai, Pulau Pinang, Malaysia

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
1
Unique Violations
6/1/2012
Latest Refusal
6/1/2012
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
6/1/2012
80LYYGLOVE, PATIENT EXAMINATION, LATEX
118NOT LISTED
Seattle District Office (SEA-DO)
6/1/2012
80LZCGLOVE, PATIENT EXAMINATION, SPECIALTY
118NOT LISTED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Harvik Rubber Industries Dsn Bhd's FDA import refusal history?

Harvik Rubber Industries Dsn Bhd (FEI: 3009310029) has 2 FDA import refusal record(s) in our database, spanning from 6/1/2012 to 6/1/2012.

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. Harvik Rubber Industries Dsn Bhd's FEI number is 3009310029.

What types of violations has Harvik Rubber Industries Dsn Bhd received?

Harvik Rubber Industries Dsn 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 Harvik Rubber Industries Dsn Bhd come from?

All FDA import refusal data for Harvik Rubber Industries Dsn 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.