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ASTRA ZENECA 119C SAN UP TIC LTD

⚠️ Moderate Risk

FEI: 3014223943 • Istanbul • TURKEY

FEI

FEI Number

3014223943

📍

Location

Istanbul

🇹🇷

Country

TURKEY
🏢

Address

Kuyukdere Cast Yapi Kie, , 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
2/26/2018
Latest Refusal
2/26/2018
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
2/26/2018
60LCA90ZOLMITRIPTAN (ANALGESIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ASTRA ZENECA 119C SAN UP TIC LTD's FDA import refusal history?

ASTRA ZENECA 119C SAN UP TIC LTD (FEI: 3014223943) has 1 FDA import refusal record(s) in our database, spanning from 2/26/2018 to 2/26/2018.

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 119C SAN UP TIC LTD's FEI number is 3014223943.

What types of violations has ASTRA ZENECA 119C SAN UP TIC LTD received?

ASTRA ZENECA 119C SAN UP TIC LTD 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 119C SAN UP TIC LTD come from?

All FDA import refusal data for ASTRA ZENECA 119C SAN UP TIC 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.