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GUARDS SURGICAL

⚠️ Moderate Risk

FEI: 3025489046 • Dhabula • PAKISTAN

FEI

FEI Number

3025489046

📍

Location

Dhabula

🇵🇰

Country

PAKISTAN
🏢

Address

Roras Rd Near Alkhidmat, , Dhabula, , Pakistan

Moderate Risk

FDA Import Risk Assessment

47.6
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/13/2023
Latest Refusal
11/13/2023
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
56.3×20%
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
11/13/2023
76NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS
290DE IMP GMP
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GUARDS SURGICAL's FDA import refusal history?

GUARDS SURGICAL (FEI: 3025489046) has 1 FDA import refusal record(s) in our database, spanning from 11/13/2023 to 11/13/2023.

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. GUARDS SURGICAL's FEI number is 3025489046.

What types of violations has GUARDS SURGICAL received?

GUARDS SURGICAL 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 GUARDS SURGICAL come from?

All FDA import refusal data for GUARDS SURGICAL 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.