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Weldon Industries (Pvt) Ltd.

⚠️ Moderate Risk

FEI: 1000547013 • Sialkot, Punjab • PAKISTAN

FEI

FEI Number

1000547013

📍

Location

Sialkot, Punjab

🇵🇰

Country

PAKISTAN
🏢

Address

Small Industries Estate, , Sialkot, Punjab, Pakistan

Moderate Risk

FDA Import Risk Assessment

25.8
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
12/8/2009
Latest Refusal
10/17/2005
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
4.8×10%
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

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).

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
12/8/2009
79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL
47NON STD
Chicago District Office (CHI-DO)
10/17/2005
80LDQDEVICE, GENERAL MEDICAL
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Weldon Industries (Pvt) Ltd.'s FDA import refusal history?

Weldon Industries (Pvt) Ltd. (FEI: 1000547013) has 2 FDA import refusal record(s) in our database, spanning from 10/17/2005 to 12/8/2009.

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. Weldon Industries (Pvt) Ltd.'s FEI number is 1000547013.

What types of violations has Weldon Industries (Pvt) Ltd. received?

Weldon Industries (Pvt) Ltd. 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 Weldon Industries (Pvt) Ltd. come from?

All FDA import refusal data for Weldon Industries (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.