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INTERNATIONAL SALES & SERVIC

⚠️ Moderate Risk

FEI: 3013578264 • Karachi • PAKISTAN

FEI

FEI Number

3013578264

📍

Location

Karachi

🇵🇰

Country

PAKISTAN
🏢

Address

302-Noor Estate, , Karachi, , Pakistan

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/22/2017
Latest Refusal
6/22/2017
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

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
6/22/2017
76ECPINSTRUMENT, LIGATURE TUCKING, ORTHODONTIC
290DE IMP GMP
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is INTERNATIONAL SALES & SERVIC's FDA import refusal history?

INTERNATIONAL SALES & SERVIC (FEI: 3013578264) has 1 FDA import refusal record(s) in our database, spanning from 6/22/2017 to 6/22/2017.

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. INTERNATIONAL SALES & SERVIC's FEI number is 3013578264.

What types of violations has INTERNATIONAL SALES & SERVIC received?

INTERNATIONAL SALES & SERVIC has been cited for 1 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 INTERNATIONAL SALES & SERVIC come from?

All FDA import refusal data for INTERNATIONAL SALES & SERVIC 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.