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New Waseem Trading

⚠️ Moderate Risk

FEI: 3004937208 • Sialkot • PAKISTAN

FEI

FEI Number

3004937208

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

Khadim Ali Road, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/11/2005
Latest Refusal
4/11/2005
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
4/11/2005
77EQLLARYNGOSTROBOSCOPE
126FAILS STD
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is New Waseem Trading's FDA import refusal history?

New Waseem Trading (FEI: 3004937208) has 1 FDA import refusal record(s) in our database, spanning from 4/11/2005 to 4/11/2005.

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. New Waseem Trading's FEI number is 3004937208.

What types of violations has New Waseem Trading received?

New Waseem Trading has been cited for 2 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 New Waseem Trading come from?

All FDA import refusal data for New Waseem Trading 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.