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Pt Mahakarya Inti Buana

⚠️ Moderate Risk

FEI: 3006196100 • Sumut • INDONESIA

FEI

FEI Number

3006196100

📍

Location

Sumut

🇮🇩

Country

INDONESIA
🏢

Address

Desa Dalu 10 A Dusun 1 No. 18tanjung, , Sumut, , Indonesia

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/28/2010
Latest Refusal
9/28/2010
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

4771×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

Refusal History

DateProductViolationsDivision
9/28/2010
80LZAGLOVE, PATIENT EXAMINATION, POLY
477HOLES
New York District Office (NYK-DO)

Frequently Asked Questions

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

Pt Mahakarya Inti Buana (FEI: 3006196100) has 1 FDA import refusal record(s) in our database, spanning from 9/28/2010 to 9/28/2010.

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 Mahakarya Inti Buana's FEI number is 3006196100.

What types of violations has Pt Mahakarya Inti Buana received?

Pt Mahakarya 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 Mahakarya Inti Buana come from?

All FDA import refusal data for Pt Mahakarya 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.