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Eltek Instrument (Pvt) Ltd.

⚠️ Moderate Risk

FEI: 3005146019 • Sialkot • PAKISTAN

FEI

FEI Number

3005146019

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

Po Box No 1468, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/28/2009
Latest Refusal
8/28/2009
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

2891×

RECORDS

The article appears to be a device and the requirements under 518 or to furnish any material or information required by or under section 519 respecting a device were not met.

Refusal History

DateProductViolationsDivision
8/28/2009
79LRWSCISSORS, GENERAL USE, SURGICAL
289RECORDS
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Eltek Instrument (Pvt) Ltd.'s FDA import refusal history?

Eltek Instrument (Pvt) Ltd. (FEI: 3005146019) has 1 FDA import refusal record(s) in our database, spanning from 8/28/2009 to 8/28/2009.

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. Eltek Instrument (Pvt) Ltd.'s FEI number is 3005146019.

What types of violations has Eltek Instrument (Pvt) Ltd. received?

Eltek Instrument (Pvt) 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 Eltek Instrument (Pvt) Ltd. come from?

All FDA import refusal data for Eltek Instrument (Pvt) 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.