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Ess Zee Ind.

⚠️ Moderate Risk

FEI: 3003781286 • Sialkot • PAKISTAN

FEI

FEI Number

3003781286

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

P.O.Box 373, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

45.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
6/4/2004
Latest Refusal
2/20/2004
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

4805×

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
6/4/2004
79GENFORCEPS, GENERAL & PLASTIC SURGERY
480STAINSTEEL
New York District Office (NYK-DO)
6/4/2004
79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY
480STAINSTEEL
New York District Office (NYK-DO)
6/4/2004
79LRWSCISSORS, GENERAL USE, SURGICAL
480STAINSTEEL
New York District Office (NYK-DO)
6/4/2004
79HTDFORCEPS
480STAINSTEEL
New York District Office (NYK-DO)
2/20/2004
76EIGRETRACTOR, ALL TYPES
480STAINSTEEL
New York District Office (NYK-DO)

Frequently Asked Questions

What is Ess Zee Ind.'s FDA import refusal history?

Ess Zee Ind. (FEI: 3003781286) has 5 FDA import refusal record(s) in our database, spanning from 2/20/2004 to 6/4/2004.

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. Ess Zee Ind.'s FEI number is 3003781286.

What types of violations has Ess Zee Ind. received?

Ess Zee Ind. 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 Ess Zee Ind. come from?

All FDA import refusal data for Ess Zee Ind. 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.