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Incekaralar Tibbi Cihazlar Tic

⚠️ Moderate Risk

FEI: 3009438934 • Ankata • TURKEY

FEI

FEI Number

3009438934

📍

Location

Ankata

🇹🇷

Country

TURKEY
🏢

Address

No 16 N Akar Mah Balgat, , Ankata, , Turkey

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
12/21/2012
Latest Refusal
12/21/2012
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

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
12/21/2012
75JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE) FOR CLINICAL USE
118NOT LISTED
New England District Office (NWE-DO)
12/21/2012
75JJEANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE) FOR CLINICAL USE
118NOT LISTED
New England District Office (NWE-DO)

Frequently Asked Questions

What is Incekaralar Tibbi Cihazlar Tic's FDA import refusal history?

Incekaralar Tibbi Cihazlar Tic (FEI: 3009438934) has 2 FDA import refusal record(s) in our database, spanning from 12/21/2012 to 12/21/2012.

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. Incekaralar Tibbi Cihazlar Tic's FEI number is 3009438934.

What types of violations has Incekaralar Tibbi Cihazlar Tic received?

Incekaralar Tibbi Cihazlar Tic 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 Incekaralar Tibbi Cihazlar Tic come from?

All FDA import refusal data for Incekaralar Tibbi Cihazlar Tic 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.