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Novartis Saglik, Gida Ve Tarim Urunleri Sanayi Ve Ticaret Anonim Sirketi

⚠️ Moderate Risk

FEI: 3004121450 • Pendik, Istanbul • TURKEY

FEI

FEI Number

3004121450

📍

Location

Pendik, Istanbul

🇹🇷

Country

TURKEY
🏢

Address

Yenisehir Mahallesi, Ihlara Vadisi Sokak No. 2, Pendik, Istanbul, Turkey

Moderate Risk

FDA Import Risk Assessment

43.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
9/28/2017
Latest Refusal
7/10/2006
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
2.7×10%
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

753×

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
9/28/2017
62LDF99ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
1/4/2007
55QG43CETYLPYRIDINIUM CHLORIDE
75UNAPPROVED
Florida District Office (FLA-DO)
7/10/2006
60LDA99ANALGESIC, N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Novartis Saglik, Gida Ve Tarim Urunleri Sanayi Ve Ticaret Anonim Sirketi's FDA import refusal history?

Novartis Saglik, Gida Ve Tarim Urunleri Sanayi Ve Ticaret Anonim Sirketi (FEI: 3004121450) has 3 FDA import refusal record(s) in our database, spanning from 7/10/2006 to 9/28/2017.

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. Novartis Saglik, Gida Ve Tarim Urunleri Sanayi Ve Ticaret Anonim Sirketi's FEI number is 3004121450.

What types of violations has Novartis Saglik, Gida Ve Tarim Urunleri Sanayi Ve Ticaret Anonim Sirketi received?

Novartis Saglik, Gida Ve Tarim Urunleri Sanayi Ve Ticaret Anonim Sirketi 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 Novartis Saglik, Gida Ve Tarim Urunleri Sanayi Ve Ticaret Anonim Sirketi come from?

All FDA import refusal data for Novartis Saglik, Gida Ve Tarim Urunleri Sanayi Ve Ticaret Anonim Sirketi 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.