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Mazur

⚠️ Moderate Risk

FEI: 3009313631 • Mangualde, Viseu • PORTUGAL

FEI

FEI Number

3009313631

📍

Location

Mangualde, Viseu

🇵🇹

Country

PORTUGAL
🏢

Address

Zona Industrial Da Lavandeira, , Mangualde, Viseu, Portugal

Moderate Risk

FDA Import Risk Assessment

49.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
2/10/2012
Latest Refusal
2/10/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

755×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
2/10/2012
66MCA99TRANQUILIZER N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)
2/10/2012
61JCA14SIMVASTATIN (ANTI-CHOLESTEREMIC)
75UNAPPROVED
New York District Office (NYK-DO)
2/10/2012
62OCA22CARVEDILOL (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
New York District Office (NYK-DO)
2/10/2012
62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
New York District Office (NYK-DO)
2/10/2012
64RCA17ANASTROZOLE (HORMONE)
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Mazur's FDA import refusal history?

Mazur (FEI: 3009313631) has 5 FDA import refusal record(s) in our database, spanning from 2/10/2012 to 2/10/2012.

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. Mazur's FEI number is 3009313631.

What types of violations has Mazur received?

Mazur 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 Mazur come from?

All FDA import refusal data for Mazur 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.