DOKUZ KIMYA ARGE DIS TIC SAN LTDSTI
⚠️ Moderate Risk
FEI: 3027400078 • Aydin • TURKEY
FEI Number
3027400078
Location
Aydin
Country
TURKEYAddress
Ata Mah, Milet Biv No 10b, Aydin, , Turkey
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is DOKUZ KIMYA ARGE DIS TIC SAN LTDSTI's FDA import refusal history?
DOKUZ KIMYA ARGE DIS TIC SAN LTDSTI (FEI: 3027400078) has 1 FDA import refusal record(s) in our database, spanning from 8/7/2023 to 8/7/2023.
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. DOKUZ KIMYA ARGE DIS TIC SAN LTDSTI's FEI number is 3027400078.
What types of violations has DOKUZ KIMYA ARGE DIS TIC SAN LTDSTI received?
DOKUZ KIMYA ARGE DIS TIC SAN LTDSTI 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 DOKUZ KIMYA ARGE DIS TIC SAN LTDSTI come from?
All FDA import refusal data for DOKUZ KIMYA ARGE DIS TIC SAN LTDSTI 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.