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Waqas Group Of Industries

⚠️ Moderate Risk

FEI: 3009465509 • Sialkot • PAKISTAN

FEI

FEI Number

3009465509

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

Islam Nagar Pacca Ghara Kashmir, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/27/2012
Latest Refusal
4/27/2012
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

2901×

DE IMP GMP

The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).

Refusal History

DateProductViolationsDivision
4/27/2012
77ESBOTOSCOPE
118NOT LISTED
290DE IMP GMP
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Waqas Group Of Industries's FDA import refusal history?

Waqas Group Of Industries (FEI: 3009465509) has 1 FDA import refusal record(s) in our database, spanning from 4/27/2012 to 4/27/2012.

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. Waqas Group Of Industries's FEI number is 3009465509.

What types of violations has Waqas Group Of Industries received?

Waqas Group Of Industries 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 Waqas Group Of Industries come from?

All FDA import refusal data for Waqas Group Of Industries 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.