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Pt Mandiri Inti Buana

⚠️ Moderate Risk

FEI: 3004456568 • Sumut • INDONESIA

FEI

FEI Number

3004456568

📍

Location

Sumut

🇮🇩

Country

INDONESIA
🏢

Address

Jl Sei Belumai Desa Dalu Sepuluh A Dusun, , Sumut, , 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
1
Unique Violations
5/5/2006
Latest Refusal
5/5/2006
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

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

Refusal History

DateProductViolationsDivision
5/5/2006
80LYYGLOVE, PATIENT EXAMINATION, LATEX
223FALSE
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is Pt Mandiri Inti Buana's FDA import refusal history?

Pt Mandiri Inti Buana (FEI: 3004456568) has 1 FDA import refusal record(s) in our database, spanning from 5/5/2006 to 5/5/2006.

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 Mandiri Inti Buana's FEI number is 3004456568.

What types of violations has Pt Mandiri Inti Buana received?

Pt Mandiri Inti Buana 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 Mandiri Inti Buana come from?

All FDA import refusal data for Pt Mandiri Inti Buana 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.