ARKAN GRUP SAGLIK URUNLERI A.S.
✅ Low Risk
FEI: 3017944438 • Tekkirdag • TURKEY
FEI Number
3017944438
Location
Tekkirdag
Country
TURKEYAddress
14 Ergene Velimese Mahallesi Haciseremet Caddesi No., , Tekkirdag, , Turkey
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
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
Frequently Asked Questions
What is ARKAN GRUP SAGLIK URUNLERI A.S.'s FDA import refusal history?
ARKAN GRUP SAGLIK URUNLERI A.S. (FEI: 3017944438) has 3 FDA import refusal record(s) in our database, spanning from 3/9/2021 to 3/9/2021.
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. ARKAN GRUP SAGLIK URUNLERI A.S.'s FEI number is 3017944438.
What types of violations has ARKAN GRUP SAGLIK URUNLERI A.S. received?
ARKAN GRUP SAGLIK URUNLERI A.S. 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 ARKAN GRUP SAGLIK URUNLERI A.S. come from?
All FDA import refusal data for ARKAN GRUP SAGLIK URUNLERI A.S. 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.