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Sandoz Syntek Ilac Hammaddeleri Sanayi Ve Ticaret A.S.

⚠️ Moderate Risk

FEI: 3008252314 • Istanbul, Istanbul • TURKEY

FEI

FEI Number

3008252314

📍

Location

Istanbul, Istanbul

🇹🇷

Country

TURKEY
🏢

Address

Caddesi No: 46, Ha8 Ozel, Parsel, Tuzla, Istanbul, 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
8/9/2010
Latest Refusal
8/9/2010
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
8/9/2010
62UAS99ANTI-TUSSIVE/COLD N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Sandoz Syntek Ilac Hammaddeleri Sanayi Ve Ticaret A.S.'s FDA import refusal history?

Sandoz Syntek Ilac Hammaddeleri Sanayi Ve Ticaret A.S. (FEI: 3008252314) has 1 FDA import refusal record(s) in our database, spanning from 8/9/2010 to 8/9/2010.

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. Sandoz Syntek Ilac Hammaddeleri Sanayi Ve Ticaret A.S.'s FEI number is 3008252314.

What types of violations has Sandoz Syntek Ilac Hammaddeleri Sanayi Ve Ticaret A.S. received?

Sandoz Syntek Ilac Hammaddeleri Sanayi Ve Ticaret A.S. 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 Sandoz Syntek Ilac Hammaddeleri Sanayi Ve Ticaret A.S. come from?

All FDA import refusal data for Sandoz Syntek Ilac Hammaddeleri Sanayi Ve Ticaret A.S. 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.