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High Scope Enterprises

⚠️ Moderate Risk

FEI: 3003459314 • Sialkot • PAKISTAN

FEI

FEI Number

3003459314

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

74-A Gulshan Street, No.2 Nishat Park, Paris Road, Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
6/3/2003
Latest Refusal
6/3/2003
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

2902×

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
6/3/2003
77JYASCISSORS, WIRE CUTTING, ENT
290DE IMP GMP
New York District Office (NYK-DO)
6/3/2003
77JYASCISSORS, WIRE CUTTING, ENT
290DE IMP GMP
New York District Office (NYK-DO)

Frequently Asked Questions

What is High Scope Enterprises's FDA import refusal history?

High Scope Enterprises (FEI: 3003459314) has 2 FDA import refusal record(s) in our database, spanning from 6/3/2003 to 6/3/2003.

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. High Scope Enterprises's FEI number is 3003459314.

What types of violations has High Scope Enterprises received?

High Scope Enterprises 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 High Scope Enterprises come from?

All FDA import refusal data for High Scope Enterprises 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.