ImportRefusal LogoImportRefusal

I.E. ULAGAY ILAC SANAYII

⚠️ Moderate Risk

FEI: 3039216462 • Istanbul • TURKEY

FEI

FEI Number

3039216462

📍

Location

Istanbul

🇹🇷

Country

TURKEY
🏢

Address

Davutpasa Caddesi No: 1, , Istanbul, , Turkey

Moderate Risk

FDA Import Risk Assessment

42.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/27/2025
Latest Refusal
8/27/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
92.4×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
8/27/2025
61XBL14CYPROHEPTADINE HCL (ANTI-HISTAMINIC)
118NOT LISTED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is I.E. ULAGAY ILAC SANAYII's FDA import refusal history?

I.E. ULAGAY ILAC SANAYII (FEI: 3039216462) has 1 FDA import refusal record(s) in our database, spanning from 8/27/2025 to 8/27/2025.

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. I.E. ULAGAY ILAC SANAYII's FEI number is 3039216462.

What types of violations has I.E. ULAGAY ILAC SANAYII received?

I.E. ULAGAY ILAC SANAYII 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 I.E. ULAGAY ILAC SANAYII come from?

All FDA import refusal data for I.E. ULAGAY ILAC SANAYII 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.