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Mazen (Bangladesh) Industries Ltd

⚠️ Moderate Risk

FEI: 3010397989 • Uttara Export Processing Zone • BANGLADESH

FEI

FEI Number

3010397989

📍

Location

Uttara Export Processing Zone

🇧🇩

Country

BANGLADESH
🏢

Address

SFB#2 (3rd Floor, Block-B, C, D & E), Plot-02-21, Sector-03, Uttara Export Processing Zone, , Bangladesh

Moderate Risk

FDA Import Risk Assessment

28.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
4/27/2022
Latest Refusal
9/8/2020
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
10.5×20%
Frequency
12.3×10%
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

32802×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
4/27/2022
86HQZFRAME, SPECTACLE
118NOT LISTED
3280FRNMFGREG
Division of Northern Border Imports (DNBI)
9/8/2020
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Mazen (Bangladesh) Industries Ltd's FDA import refusal history?

Mazen (Bangladesh) Industries Ltd (FEI: 3010397989) has 2 FDA import refusal record(s) in our database, spanning from 9/8/2020 to 4/27/2022.

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. Mazen (Bangladesh) Industries Ltd's FEI number is 3010397989.

What types of violations has Mazen (Bangladesh) Industries Ltd received?

Mazen (Bangladesh) Industries Ltd 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 Mazen (Bangladesh) Industries Ltd come from?

All FDA import refusal data for Mazen (Bangladesh) Industries Ltd 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.