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TEMKO TEMIZLIK KOZMETIK VE GIDA SANAYI TICARET LIMITED SIRKETI

✅ Low Risk

FEI: 3006629196 • CORLU • TURKEY

FEI

FEI Number

3006629196

📍

Location

CORLU

🇹🇷

Country

TURKEY
🏢

Address

NO:14-1 TURK GUCU OSB MAHALLESI 216 SOKAK, , CORLU, , Turkey

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
11/17/2010
Latest Refusal
11/17/2010
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
11/17/2010
76EFWTOOTHBRUSH, MANUAL
341REGISTERED
New York District Office (NYK-DO)

Frequently Asked Questions

What is TEMKO TEMIZLIK KOZMETIK VE GIDA SANAYI TICARET LIMITED SIRKETI's FDA import refusal history?

TEMKO TEMIZLIK KOZMETIK VE GIDA SANAYI TICARET LIMITED SIRKETI (FEI: 3006629196) has 1 FDA import refusal record(s) in our database, spanning from 11/17/2010 to 11/17/2010.

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. TEMKO TEMIZLIK KOZMETIK VE GIDA SANAYI TICARET LIMITED SIRKETI's FEI number is 3006629196.

What types of violations has TEMKO TEMIZLIK KOZMETIK VE GIDA SANAYI TICARET LIMITED SIRKETI received?

TEMKO TEMIZLIK KOZMETIK VE GIDA SANAYI TICARET LIMITED SIRKETI 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 TEMKO TEMIZLIK KOZMETIK VE GIDA SANAYI TICARET LIMITED SIRKETI come from?

All FDA import refusal data for TEMKO TEMIZLIK KOZMETIK VE GIDA SANAYI TICARET LIMITED SIRKETI 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.