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Kardesler Ucan Yaglar Sanayi Anonim Sirketi

⚠️ Moderate Risk

FEI: 3012634391 • Gebze, Kocaeli • TURKEY

FEI

FEI Number

3012634391

📍

Location

Gebze, Kocaeli

🇹🇷

Country

TURKEY
🏢

Address

No:1 Inonu Mahallesi Gebze, Plastikciler OSB. Mahallesi 42, Gebze, Kocaeli, Turkey

Moderate Risk

FDA Import Risk Assessment

32.4
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
9/27/2022
Latest Refusal
9/27/2022
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
20.2×20%
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

3101×

POISONOUS

The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
9/27/2022
53AY04BABY WIPES
310POISONOUS
471CSTIC LBLG
473LABELING
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Kardesler Ucan Yaglar Sanayi Anonim Sirketi's FDA import refusal history?

Kardesler Ucan Yaglar Sanayi Anonim Sirketi (FEI: 3012634391) has 1 FDA import refusal record(s) in our database, spanning from 9/27/2022 to 9/27/2022.

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. Kardesler Ucan Yaglar Sanayi Anonim Sirketi's FEI number is 3012634391.

What types of violations has Kardesler Ucan Yaglar Sanayi Anonim Sirketi received?

Kardesler Ucan Yaglar Sanayi Anonim Sirketi 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 Kardesler Ucan Yaglar Sanayi Anonim Sirketi come from?

All FDA import refusal data for Kardesler Ucan Yaglar Sanayi Anonim 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.