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UD. Mitra Mandiri

⚠️ Moderate Risk

FEI: 3005085334 • Surabaya, Jawa Timur • INDONESIA

FEI

FEI Number

3005085334

📍

Location

Surabaya, Jawa Timur

🇮🇩

Country

INDONESIA
🏢

Address

Jln. Barata Jaya 56, , Surabaya, Jawa Timur, Indonesia

Moderate Risk

FDA Import Risk Assessment

38.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
9/7/2007
Latest Refusal
7/3/2007
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
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

2492×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

3241×

NO ENGLISH

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

Refusal History

DateProductViolationsDivision
9/7/2007
54GAT04SHARK (ANIMAL BY-PRODUCTS AND EXTRACTS)
249FILTHY
324NO ENGLISH
Florida District Office (FLA-DO)
7/3/2007
54GAT04SHARK (ANIMAL BY-PRODUCTS AND EXTRACTS)
249FILTHY
Florida District Office (FLA-DO)

Frequently Asked Questions

What is UD. Mitra Mandiri's FDA import refusal history?

UD. Mitra Mandiri (FEI: 3005085334) has 2 FDA import refusal record(s) in our database, spanning from 7/3/2007 to 9/7/2007.

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. UD. Mitra Mandiri's FEI number is 3005085334.

What types of violations has UD. Mitra Mandiri received?

UD. Mitra Mandiri 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 UD. Mitra Mandiri come from?

All FDA import refusal data for UD. Mitra Mandiri 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.