MEDIZOLE ENTERPRISES

⚠️ High Risk

FEI: 3022777876 • Sialkota • PAKISTAN

FEI

FEI Number

3022777876

📍

Location

Sialkota

🇵🇰

Country

PAKISTAN

🏢

Address

Near Roras Road Chowk, , Sialkota, , Pakistan

High Risk

FDA Import Risk Assessment

64.3

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

2/8/2023

Latest Refusal

2/8/2023

Earliest Refusal

Score Breakdown

Violation Severity

80.0×40%

Refusal Volume

46.5×30%

Recency

41.5×20%

Frequency

100.0×10%

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

Violation Summary

29017×

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

Date	Product	Violations	Division
2/8/2023	76EGNSCISSORS, SURGICAL TISSUE, DENTAL	290DE IMP GMP	Division of Northeast Imports (DNEI)
2/8/2023	76EMNSCALER, PERIODONTIC	290DE IMP GMP	Division of Northeast Imports (DNEI)
2/8/2023	76ELZCROWN, PREFORMED	290DE IMP GMP	Division of Northeast Imports (DNEI)
2/8/2023	76EGNSCISSORS, SURGICAL TISSUE, DENTAL	290DE IMP GMP	Division of Northeast Imports (DNEI)
2/8/2023	76EGNSCISSORS, SURGICAL TISSUE, DENTAL	290DE IMP GMP	Division of Northeast Imports (DNEI)
2/8/2023	76EGNSCISSORS, SURGICAL TISSUE, DENTAL	290DE IMP GMP	Division of Northeast Imports (DNEI)
2/8/2023	76EGNSCISSORS, SURGICAL TISSUE, DENTAL	290DE IMP GMP	Division of Northeast Imports (DNEI)
2/8/2023	76EGNSCISSORS, SURGICAL TISSUE, DENTAL	290DE IMP GMP	Division of Northeast Imports (DNEI)
2/8/2023	76EGNSCISSORS, SURGICAL TISSUE, DENTAL	290DE IMP GMP	Division of Northeast Imports (DNEI)
2/8/2023	76EGNSCISSORS, SURGICAL TISSUE, DENTAL	290DE IMP GMP	Division of Northeast Imports (DNEI)
2/8/2023	76EGNSCISSORS, SURGICAL TISSUE, DENTAL	290DE IMP GMP	Division of Northeast Imports (DNEI)
2/8/2023	76EEFCLAMP, RUBBER DAM	290DE IMP GMP	Division of Northeast Imports (DNEI)
2/8/2023	76EEFCLAMP, RUBBER DAM	290DE IMP GMP	Division of Northeast Imports (DNEI)
2/8/2023	76EEFCLAMP, RUBBER DAM	290DE IMP GMP	Division of Northeast Imports (DNEI)
2/8/2023	76EEFCLAMP, RUBBER DAM	290DE IMP GMP	Division of Northeast Imports (DNEI)
2/8/2023	76EEFCLAMP, RUBBER DAM	290DE IMP GMP	Division of Northeast Imports (DNEI)
2/8/2023	76EEFCLAMP, RUBBER DAM	290DE IMP GMP	Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is MEDIZOLE ENTERPRISES's FDA import refusal history?

MEDIZOLE ENTERPRISES (FEI: 3022777876) has 17 FDA import refusal record(s) in our database, spanning from 2/8/2023 to 2/8/2023.

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. MEDIZOLE ENTERPRISES's FEI number is 3022777876.

What types of violations has MEDIZOLE ENTERPRISES received?

MEDIZOLE ENTERPRISES 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 MEDIZOLE ENTERPRISES come from?

All FDA import refusal data for MEDIZOLE ENTERPRISES 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.