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WALEED HASSAN

⚠️ Moderate Risk

FEI: 3030017651 • Sialkot • PAKISTAN

FEI

FEI Number

3030017651

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

Umer Center Shahab Pura, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
1/12/2024
Latest Refusal
1/12/2024
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
59.5×20%
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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
1/12/2024
76EFLFORCEPS, DRESSING, DENTAL
118NOT LISTED
290DE IMP GMP
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is WALEED HASSAN's FDA import refusal history?

WALEED HASSAN (FEI: 3030017651) has 1 FDA import refusal record(s) in our database, spanning from 1/12/2024 to 1/12/2024.

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. WALEED HASSAN's FEI number is 3030017651.

What types of violations has WALEED HASSAN received?

WALEED HASSAN has been cited for 3 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 WALEED HASSAN come from?

All FDA import refusal data for WALEED HASSAN 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.