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PT Delta Waru Rubber Industry

⚠️ Moderate Risk

FEI: 3800 • Waru, Sidoarjo • INDONESIA

FEI

FEI Number

3800

📍

Location

Waru, Sidoarjo

🇮🇩

Country

INDONESIA
🏢

Address

2 Brigjen Katamso St, , Waru, Sidoarjo, Indonesia

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/6/2004
Latest Refusal
10/6/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

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
10/6/2004
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is PT Delta Waru Rubber Industry's FDA import refusal history?

PT Delta Waru Rubber Industry (FEI: 3800) has 1 FDA import refusal record(s) in our database, spanning from 10/6/2004 to 10/6/2004.

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. PT Delta Waru Rubber Industry's FEI number is 3800.

What types of violations has PT Delta Waru Rubber Industry received?

PT Delta Waru Rubber Industry 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 PT Delta Waru Rubber Industry come from?

All FDA import refusal data for PT Delta Waru Rubber Industry 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.