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ISMO DINAMIK SISTEMLER MAK SAN VE TIC LTD STI

⚠️ Moderate Risk

FEI: 3033871375 • Izmir • TURKEY

FEI

FEI Number

3033871375

📍

Location

Izmir

🇹🇷

Country

TURKEY
🏢

Address

29 Ekim Mahallesi 10007sokak No.18/40 Cina, Sanayi Sitesi Ulukent, Izmir, , Turkey

Moderate Risk

FDA Import Risk Assessment

46.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/25/2025
Latest Refusal
2/25/2025
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
11.2×30%
Recency
82.2×20%
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

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
2/25/2025
95RHKLASER MARKER OR ENGRAVER
47NON STD
476NO REGISTR
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ISMO DINAMIK SISTEMLER MAK SAN VE TIC LTD STI's FDA import refusal history?

ISMO DINAMIK SISTEMLER MAK SAN VE TIC LTD STI (FEI: 3033871375) has 1 FDA import refusal record(s) in our database, spanning from 2/25/2025 to 2/25/2025.

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. ISMO DINAMIK SISTEMLER MAK SAN VE TIC LTD STI's FEI number is 3033871375.

What types of violations has ISMO DINAMIK SISTEMLER MAK SAN VE TIC LTD STI received?

ISMO DINAMIK SISTEMLER MAK SAN VE TIC LTD STI has been cited for 2 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 ISMO DINAMIK SISTEMLER MAK SAN VE TIC LTD STI come from?

All FDA import refusal data for ISMO DINAMIK SISTEMLER MAK SAN VE TIC LTD STI 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.