GOKTURK GLOBAL DIS TICARET A.S.
⚠️ Moderate Risk
FEI: 3017381136 • Izmir • TURKEY
FEI Number
3017381136
Location
Izmir
Country
TURKEYAddress
Atif Bey Mah 5/3 Sok No9 D 401 Gaz, , Izmir, , 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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/31/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 5/31/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Northeast Imports (DNEI) |
| 5/31/2022 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | 508NO 510(K) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is GOKTURK GLOBAL DIS TICARET A.S.'s FDA import refusal history?
GOKTURK GLOBAL DIS TICARET A.S. (FEI: 3017381136) has 3 FDA import refusal record(s) in our database, spanning from 5/31/2022 to 5/31/2022.
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. GOKTURK GLOBAL DIS TICARET A.S.'s FEI number is 3017381136.
What types of violations has GOKTURK GLOBAL DIS TICARET A.S. received?
GOKTURK GLOBAL DIS TICARET 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 GOKTURK GLOBAL DIS TICARET A.S. come from?
All FDA import refusal data for GOKTURK GLOBAL DIS TICARET 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.