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Pt. Indorub Nusaraya

⚠️ Moderate Risk

FEI: 1000261016 • Sumatera Utara • INDONESIA

FEI

FEI Number

1000261016

📍

Location

Sumatera Utara

🇮🇩

Country

INDONESIA
🏢

Address

Jl. Batang Kuis Psr 9 Harapan 88, Ji. Semarang No. 105/16 Medan, Sumatera Utara, , Indonesia

Moderate Risk

FDA Import Risk Assessment

39.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
10/4/2006
Latest Refusal
7/17/2006
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

4774×

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
10/4/2006
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Chicago District Office (CHI-DO)
9/18/2006
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Chicago District Office (CHI-DO)
8/30/2006
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Chicago District Office (CHI-DO)
7/17/2006
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Pt. Indorub Nusaraya's FDA import refusal history?

Pt. Indorub Nusaraya (FEI: 1000261016) has 4 FDA import refusal record(s) in our database, spanning from 7/17/2006 to 10/4/2006.

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. Indorub Nusaraya's FEI number is 1000261016.

What types of violations has Pt. Indorub Nusaraya received?

Pt. Indorub Nusaraya 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. Indorub Nusaraya come from?

All FDA import refusal data for Pt. Indorub Nusaraya 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.