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PT. Aditama Sentosa Indonesia

⚠️ High Risk

FEI: 3017705679 • Malang, Jawa Timur • INDONESIA

FEI

FEI Number

3017705679

📍

Location

Malang, Jawa Timur

🇮🇩

Country

INDONESIA
🏢

Address

Blok A1, Jl. Candra Kirana, Malang, Jawa Timur, Indonesia

High Risk

FDA Import Risk Assessment

53.2
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

3
Total Refusals
1
Unique Violations
6/6/2024
Latest Refusal
3/23/2021
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
22.3×30%
Recency
68.0×20%
Frequency
9.3×10%
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

21203×

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
6/6/2024
54KBT12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2120UNSFDIETSP
Division of West Coast Imports (DWCI)
8/18/2021
54JYY12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED)
2120UNSFDIETSP
Division of Northeast Imports (DNEI)
3/23/2021
54JFT12KRATOM (HERBAL AND BOTANICAL TEAS II, CONTINUED)
2120UNSFDIETSP
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is PT. Aditama Sentosa Indonesia's FDA import refusal history?

PT. Aditama Sentosa Indonesia (FEI: 3017705679) has 3 FDA import refusal record(s) in our database, spanning from 3/23/2021 to 6/6/2024.

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. Aditama Sentosa Indonesia's FEI number is 3017705679.

What types of violations has PT. Aditama Sentosa Indonesia received?

PT. Aditama Sentosa Indonesia 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. Aditama Sentosa Indonesia come from?

All FDA import refusal data for PT. Aditama Sentosa Indonesia 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.