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Edward Setiawan

⚠️ Moderate Risk

FEI: 3011681362 • Jakarta, Jabotabek • INDONESIA

FEI

FEI Number

3011681362

📍

Location

Jakarta, Jabotabek

🇮🇩

Country

INDONESIA
🏢

Address

No 238 Jln. Imam Bonjol, , Jakarta, Jabotabek, Indonesia

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/1/2015
Latest Refusal
10/1/2015
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

21201×

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
10/1/2015
54Y99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2120UNSFDIETSP
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Edward Setiawan's FDA import refusal history?

Edward Setiawan (FEI: 3011681362) has 1 FDA import refusal record(s) in our database, spanning from 10/1/2015 to 10/1/2015.

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. Edward Setiawan's FEI number is 3011681362.

What types of violations has Edward Setiawan received?

Edward 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 Edward Setiawan come from?

All FDA import refusal data for Edward 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.