ImportRefusal LogoImportRefusal

Mitra Organic

⚠️ Moderate Risk

FEI: 3012046070 • Medan • INDONESIA

FEI

FEI Number

3012046070

📍

Location

Medan

🇮🇩

Country

INDONESIA
🏢

Address

Ji.Pembangungunan No. 110, , Medan, , Indonesia

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
3/25/2016
Latest Refusal
3/25/2016
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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.

4731×

LABELING

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

Refusal History

DateProductViolationsDivision
3/25/2016
54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2120UNSFDIETSP
473LABELING
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Mitra Organic's FDA import refusal history?

Mitra Organic (FEI: 3012046070) has 1 FDA import refusal record(s) in our database, spanning from 3/25/2016 to 3/25/2016.

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. Mitra Organic's FEI number is 3012046070.

What types of violations has Mitra Organic received?

Mitra Organic has been cited for 2 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 Mitra Organic come from?

All FDA import refusal data for Mitra Organic 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.