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A&E International Company

⚠️ Moderate Risk

FEI: 3001168700 • Sialkot, Punjab • PAKISTAN

FEI

FEI Number

3001168700

📍

Location

Sialkot, Punjab

🇵🇰

Country

PAKISTAN
🏢

Address

Wazirabad Road, , Sialkot, Punjab, Pakistan

Moderate Risk

FDA Import Risk Assessment

37.4
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
10/15/2005
Latest Refusal
7/15/2003
Earliest Refusal

Score Breakdown

Violation Severity
73.3×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
13.3×10%
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

27802×

DEVICEGMPS

The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.

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
10/15/2005
76EGNSCISSORS, SURGICAL TISSUE, DENTAL
480STAINSTEEL
Los Angeles District Office (LOS-DO)
3/30/2004
73CALLARYNGOSCOPE, NON-RIGID
2780DEVICEGMPS
Seattle District Office (SEA-DO)
7/15/2003
77ETFUNIT, EXAMINING/TREATMENT, ENT
2780DEVICEGMPS
Florida District Office (FLA-DO)

Frequently Asked Questions

What is A&E International Company's FDA import refusal history?

A&E International Company (FEI: 3001168700) has 3 FDA import refusal record(s) in our database, spanning from 7/15/2003 to 10/15/2005.

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. A&E International Company's FEI number is 3001168700.

What types of violations has A&E International Company received?

A&E International 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 A&E International Company come from?

All FDA import refusal data for A&E International 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.