ImportRefusal LogoImportRefusal

Istanbul Universitesi Cerrahpasa Tip Fakultesi Dekanligi

⚠️ Moderate Risk

FEI: 3005713830 • Istanbul • TURKEY

FEI

FEI Number

3005713830

📍

Location

Istanbul

🇹🇷

Country

TURKEY
🏢

Address

Vezneciler, , Istanbul, , Turkey

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
6/24/2010
Latest Refusal
6/24/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

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
6/24/2010
61XCA99ANTI-HISTAMINIC N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)
6/24/2010
62UCA02BUTAMIRATE CITRATE (ANTI-TUSSIVE/COLD)
75UNAPPROVED
New York District Office (NYK-DO)
6/24/2010
60LCA05ASPIRIN (ANALGESIC)
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Istanbul Universitesi Cerrahpasa Tip Fakultesi Dekanligi's FDA import refusal history?

Istanbul Universitesi Cerrahpasa Tip Fakultesi Dekanligi (FEI: 3005713830) has 3 FDA import refusal record(s) in our database, spanning from 6/24/2010 to 6/24/2010.

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. Istanbul Universitesi Cerrahpasa Tip Fakultesi Dekanligi's FEI number is 3005713830.

What types of violations has Istanbul Universitesi Cerrahpasa Tip Fakultesi Dekanligi received?

Istanbul Universitesi Cerrahpasa Tip Fakultesi Dekanligi 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 Istanbul Universitesi Cerrahpasa Tip Fakultesi Dekanligi come from?

All FDA import refusal data for Istanbul Universitesi Cerrahpasa Tip Fakultesi Dekanligi 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.