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Athle Surgico

⚠️ Moderate Risk

FEI: 1000634127 • Sialkot, Punjab • PAKISTAN

FEI

FEI Number

1000634127

📍

Location

Sialkot, Punjab

🇵🇰

Country

PAKISTAN
🏢

Address

(Railway Gate) Mubarik Pura, , Sialkot, Punjab, Pakistan

Moderate Risk

FDA Import Risk Assessment

41.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
7/26/2010
Latest Refusal
11/4/2009
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

4803×

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
7/26/2010
79HTDFORCEPS
480STAINSTEEL
New Orleans District Office (NOL-DO)
7/26/2010
79HTCPLIERS, SURGICAL
480STAINSTEEL
New Orleans District Office (NOL-DO)
11/4/2009
80JOKSCISSORS, MEDICAL, DISPOSABLE
480STAINSTEEL
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Athle Surgico's FDA import refusal history?

Athle Surgico (FEI: 1000634127) has 3 FDA import refusal record(s) in our database, spanning from 11/4/2009 to 7/26/2010.

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. Athle Surgico's FEI number is 1000634127.

What types of violations has Athle Surgico received?

Athle Surgico 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 Athle Surgico come from?

All FDA import refusal data for Athle Surgico 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.