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Shaariq Sultan International/ Sultan Group of Companies

⚠️ Moderate Risk

FEI: 3004719509 • Sialkot • PAKISTAN

FEI

FEI Number

3004719509

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

P.O. Box 2273, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
1/19/2005
Latest Refusal
1/19/2005
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
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).

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).

4801×

STAINSTEEL

The article appears to be a device whose quality falls below that which it purports or is represented to possess, in that instrument is represented as stainless steel but does not meet requirements for such steel for surgical instruments.

Refusal History

DateProductViolationsDivision
1/19/2005
77ERAOTOSCOPE
118NOT LISTED
341REGISTERED
480STAINSTEEL
New York District Office (NYK-DO)

Frequently Asked Questions

What is Shaariq Sultan International/ Sultan Group of Companies's FDA import refusal history?

Shaariq Sultan International/ Sultan Group of Companies (FEI: 3004719509) has 1 FDA import refusal record(s) in our database, spanning from 1/19/2005 to 1/19/2005.

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. Shaariq Sultan International/ Sultan Group of Companies's FEI number is 3004719509.

What types of violations has Shaariq Sultan International/ Sultan Group of Companies received?

Shaariq Sultan International/ Sultan Group of Companies 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 Shaariq Sultan International/ Sultan Group of Companies come from?

All FDA import refusal data for Shaariq Sultan International/ Sultan Group of Companies 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.