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Erlan Setiawan

⚠️ Moderate Risk

FEI: 3009627826 • Pontianak, Kalimantan Barat • INDONESIA

FEI

FEI Number

3009627826

📍

Location

Pontianak, Kalimantan Barat

🇮🇩

Country

INDONESIA
🏢

Address

Jln. Semangai Panglima 28, , Pontianak, Kalimantan Barat, Indonesia

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
9/13/2012
Latest Refusal
8/23/2012
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

21202×

UNSFDIETSP

The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.

Refusal History

DateProductViolationsDivision
9/13/2012
54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2120UNSFDIETSP
Seattle District Office (SEA-DO)
8/23/2012
54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2120UNSFDIETSP
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Erlan Setiawan's FDA import refusal history?

Erlan Setiawan (FEI: 3009627826) has 2 FDA import refusal record(s) in our database, spanning from 8/23/2012 to 9/13/2012.

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. Erlan Setiawan's FEI number is 3009627826.

What types of violations has Erlan Setiawan received?

Erlan Setiawan 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 Erlan Setiawan come from?

All FDA import refusal data for Erlan Setiawan 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.