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Hobri International

⚠️ Moderate Risk

FEI: 3002807195 • Sialkot • PAKISTAN

FEI

FEI Number

3002807195

📍

Location

Sialkot

🇵🇰

Country

PAKISTAN
🏢

Address

Defence Rd. Fateh Garh, , Sialkot, , Pakistan

Moderate Risk

FDA Import Risk Assessment

45.5
LowModerateHighCritical

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

Statistics

7
Total Refusals
2
Unique Violations
12/16/2004
Latest Refusal
6/6/2003
Earliest Refusal

Score Breakdown

Violation Severity
77.1×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
45.7×10%
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

4805×

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.

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
12/16/2004
79HTDFORCEPS
480STAINSTEEL
Chicago District Office (CHI-DO)
12/16/2004
87HRRSCISSORS
480STAINSTEEL
Chicago District Office (CHI-DO)
6/29/2004
74LDESTETHOSCOPE, MANUAL
508NO 510(K)
Florida District Office (FLA-DO)
6/29/2004
85HDFSPECULUM, VAGINAL, METAL
508NO 510(K)
Florida District Office (FLA-DO)
6/6/2003
87HXBPROBE
480STAINSTEEL
Chicago District Office (CHI-DO)
6/6/2003
79HTDFORCEPS
480STAINSTEEL
Chicago District Office (CHI-DO)
6/6/2003
87HRRSCISSORS
480STAINSTEEL
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Hobri International's FDA import refusal history?

Hobri International (FEI: 3002807195) has 7 FDA import refusal record(s) in our database, spanning from 6/6/2003 to 12/16/2004.

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. Hobri International's FEI number is 3002807195.

What types of violations has Hobri International received?

Hobri International 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 Hobri International come from?

All FDA import refusal data for Hobri International 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.