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Pakistan Surgical Industries Ltd.

⚠️ Moderate Risk

FEI: 3000136335 • Sialkot • PAKISTAN

FEI

FEI Number

3000136335

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

P. O. Box 795, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
10/18/2010
Latest Refusal
2/6/2010
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

4802×

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
10/18/2010
76ELCSCALER, ULTRASONIC
480STAINSTEEL
New York District Office (NYK-DO)
2/6/2010
76EMNSCALER, PERIODONTIC
480STAINSTEEL
New York District Office (NYK-DO)

Frequently Asked Questions

What is Pakistan Surgical Industries Ltd.'s FDA import refusal history?

Pakistan Surgical Industries Ltd. (FEI: 3000136335) has 2 FDA import refusal record(s) in our database, spanning from 2/6/2010 to 10/18/2010.

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. Pakistan Surgical Industries Ltd.'s FEI number is 3000136335.

What types of violations has Pakistan Surgical Industries Ltd. received?

Pakistan Surgical Industries Ltd. 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 Pakistan Surgical Industries Ltd. come from?

All FDA import refusal data for Pakistan Surgical Industries Ltd. 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.