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Chand Jee Manufacturing Company

⚠️ Moderate Risk

FEI: 3001109435 • Sialkot • PAKISTAN

FEI

FEI Number

3001109435

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

Jinnah Islamia College Road, P.O. Box 1255, Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
3/31/2003
Latest Refusal
3/31/2003
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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

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
3/31/2003
79HTDFORCEPS
341REGISTERED
480STAINSTEEL
New York District Office (NYK-DO)

Frequently Asked Questions

What is Chand Jee Manufacturing Company's FDA import refusal history?

Chand Jee Manufacturing Company (FEI: 3001109435) has 1 FDA import refusal record(s) in our database, spanning from 3/31/2003 to 3/31/2003.

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. Chand Jee Manufacturing Company's FEI number is 3001109435.

What types of violations has Chand Jee Manufacturing Company received?

Chand Jee Manufacturing Company 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 Chand Jee Manufacturing Company come from?

All FDA import refusal data for Chand Jee Manufacturing Company 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.