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ORGANIK KIMYA SANAYI VE TICARET

⚠️ Moderate Risk

FEI: 3024216651 • Istanbul • TURKEY

FEI

FEI Number

3024216651

📍

Location

Istanbul

🇹🇷

Country

TURKEY
🏢

Address

Cendere Yolu #15-80870, , Istanbul, , Turkey

Moderate Risk

FDA Import Risk Assessment

45.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/8/2022
Latest Refusal
12/8/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
24.1×20%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
12/8/2022
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ORGANIK KIMYA SANAYI VE TICARET's FDA import refusal history?

ORGANIK KIMYA SANAYI VE TICARET (FEI: 3024216651) has 1 FDA import refusal record(s) in our database, spanning from 12/8/2022 to 12/8/2022.

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. ORGANIK KIMYA SANAYI VE TICARET's FEI number is 3024216651.

What types of violations has ORGANIK KIMYA SANAYI VE TICARET received?

ORGANIK KIMYA SANAYI VE TICARET 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 ORGANIK KIMYA SANAYI VE TICARET come from?

All FDA import refusal data for ORGANIK KIMYA SANAYI VE TICARET 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.