ImportRefusal LogoImportRefusal

VERDE DIS TIC TAS SAN LTD

⚠️ Moderate Risk

FEI: 3021086575 • Istanbul • TURKEY

FEI

FEI Number

3021086575

📍

Location

Istanbul

🇹🇷

Country

TURKEY
🏢

Address

Orucreis Mah Tekstilkent, , Istanbul, , Turkey

Moderate Risk

FDA Import Risk Assessment

47.1
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
8/13/2025
Latest Refusal
1/24/2025
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
22.3×30%
Recency
77.1×20%
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

1183×

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).

32803×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
8/13/2025
75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
118NOT LISTED
3280FRNMFGREG
508NO 510(K)
Division of Southeast Imports (DSEI)
3/14/2025
80FMINEEDLE, HYPODERMIC, SINGLE LUMEN
118NOT LISTED
3280FRNMFGREG
Division of Southeast Imports (DSEI)
1/24/2025
86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE
118NOT LISTED
3280FRNMFGREG
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is VERDE DIS TIC TAS SAN LTD's FDA import refusal history?

VERDE DIS TIC TAS SAN LTD (FEI: 3021086575) has 3 FDA import refusal record(s) in our database, spanning from 1/24/2025 to 8/13/2025.

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. VERDE DIS TIC TAS SAN LTD's FEI number is 3021086575.

What types of violations has VERDE DIS TIC TAS SAN LTD received?

VERDE DIS TIC TAS SAN LTD has been cited for 3 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 VERDE DIS TIC TAS SAN LTD come from?

All FDA import refusal data for VERDE DIS TIC TAS SAN 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.