Define Hediyelik Esya Ic Ve Dis
⚠️ Moderate Risk
FEI: 3009455009 • Istanbul • TURKEY
FEI Number
3009455009
Location
Istanbul
Country
TURKEYAddress
Tomruk Sk No 24, , Istanbul, , 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
Frequently Asked Questions
What is Define Hediyelik Esya Ic Ve Dis's FDA import refusal history?
Define Hediyelik Esya Ic Ve Dis (FEI: 3009455009) has 1 FDA import refusal record(s) in our database, spanning from 4/20/2012 to 4/20/2012.
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. Define Hediyelik Esya Ic Ve Dis's FEI number is 3009455009.
What types of violations has Define Hediyelik Esya Ic Ve Dis received?
Define Hediyelik Esya Ic Ve Dis has been cited for 4 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 Define Hediyelik Esya Ic Ve Dis come from?
All FDA import refusal data for Define Hediyelik Esya Ic Ve Dis 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.