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Prime Star Instruments

⚠️ Moderate Risk

FEI: 3004509651 • Sialkot • PAKISTAN

FEI

FEI Number

3004509651

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

P O Box 1981, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/28/2005
Latest Refusal
3/28/2005
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

4801×

STAINSTEEL

The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.

Refusal History

DateProductViolationsDivision
3/28/2005
87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT
480STAINSTEEL
New York District Office (NYK-DO)

Frequently Asked Questions

What is Prime Star Instruments's FDA import refusal history?

Prime Star Instruments (FEI: 3004509651) has 1 FDA import refusal record(s) in our database, spanning from 3/28/2005 to 3/28/2005.

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. Prime Star Instruments's FEI number is 3004509651.

What types of violations has Prime Star Instruments received?

Prime Star Instruments 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 Prime Star Instruments come from?

All FDA import refusal data for Prime Star Instruments 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.