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CV DIEN

⚠️ Moderate Risk

FEI: 3015257125 • Jawa Tengah • INDONESIA

FEI

FEI Number

3015257125

📍

Location

Jawa Tengah

🇮🇩

Country

INDONESIA
🏢

Address

Jl Aeteri Soekarnohattad-4, Kel Sawah Besar Kec, Gayamsari, Kota Semarang, , Jawa Tengah, , Indonesia

Moderate Risk

FDA Import Risk Assessment

33.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
5/16/2020
Latest Refusal
5/16/2020
Earliest Refusal

Score Breakdown

Violation Severity
73.3×40%
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.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

91×

SALMONELLA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.

Refusal History

DateProductViolationsDivision
5/16/2020
54KYT12KRATOM (HERBAL AND BOTANICALS, NOT TEAS II)
2120UNSFDIETSP
473LABELING
9SALMONELLA
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is CV DIEN's FDA import refusal history?

CV DIEN (FEI: 3015257125) has 1 FDA import refusal record(s) in our database, spanning from 5/16/2020 to 5/16/2020.

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. CV DIEN's FEI number is 3015257125.

What types of violations has CV DIEN received?

CV DIEN has been cited for 3 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 CV DIEN come from?

All FDA import refusal data for CV DIEN 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.