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Astra Zeneca Ilsa Ltd Sti

⚠️ Moderate Risk

FEI: 3008403581 • Istanbul • TURKEY

FEI

FEI Number

3008403581

📍

Location

Istanbul

🇹🇷

Country

TURKEY
🏢

Address

Buyukdere C Plazab Blk, , Istanbul, , Turkey

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/30/2011
Latest Refusal
12/30/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

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
12/30/2011
66NCB03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Astra Zeneca Ilsa Ltd Sti's FDA import refusal history?

Astra Zeneca Ilsa Ltd Sti (FEI: 3008403581) has 1 FDA import refusal record(s) in our database, spanning from 12/30/2011 to 12/30/2011.

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. Astra Zeneca Ilsa Ltd Sti's FEI number is 3008403581.

What types of violations has Astra Zeneca Ilsa Ltd Sti received?

Astra Zeneca Ilsa Ltd Sti 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 Astra Zeneca Ilsa Ltd Sti come from?

All FDA import refusal data for Astra Zeneca Ilsa Ltd Sti 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.