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Mts Brothers Surgical Instruments

⚠️ Moderate Risk

FEI: 3005353020 • Sialkot, Punjab • PAKISTAN

FEI

FEI Number

3005353020

📍

Location

Sialkot, Punjab

🇵🇰

Country

PAKISTAN
🏢

Address

Kotly Loharan East, 210-Mohallah Chore, Sialkot, Punjab, Pakistan

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/24/2006
Latest Refusal
4/24/2006
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

2901×

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
4/24/2006
79HTDFORCEPS
290DE IMP GMP
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Mts Brothers Surgical Instruments's FDA import refusal history?

Mts Brothers Surgical Instruments (FEI: 3005353020) has 1 FDA import refusal record(s) in our database, spanning from 4/24/2006 to 4/24/2006.

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. Mts Brothers Surgical Instruments's FEI number is 3005353020.

What types of violations has Mts Brothers Surgical Instruments received?

Mts Brothers Surgical Instruments 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 Mts Brothers Surgical Instruments come from?

All FDA import refusal data for Mts Brothers Surgical Instruments 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.