ERYIGIT END MAK SAN VE TIC AS
⚠️ Moderate Risk
FEI: 3016799350 • Yenimahalle, Ankara • TURKEY
FEI Number
3016799350
Location
Yenimahalle, Ankara
Country
TURKEYAddress
1453 Sok., , Yenimahalle, Ankara, 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 |
|---|---|---|---|
| 5/29/2020 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ERYIGIT END MAK SAN VE TIC AS's FDA import refusal history?
ERYIGIT END MAK SAN VE TIC AS (FEI: 3016799350) has 1 FDA import refusal record(s) in our database, spanning from 5/29/2020 to 5/29/2020.
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. ERYIGIT END MAK SAN VE TIC AS's FEI number is 3016799350.
What types of violations has ERYIGIT END MAK SAN VE TIC AS received?
ERYIGIT END MAK SAN VE TIC AS 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 ERYIGIT END MAK SAN VE TIC AS come from?
All FDA import refusal data for ERYIGIT END MAK SAN VE TIC AS 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.