Sudem Gida Ic Ve Dis Tic Ltd.
⚠️ Moderate Risk
FEI: 3004155064 • Izmir • TURKEY
FEI Number
3004155064
Location
Izmir
Country
TURKEYAddress
Mimar Kemalettin Cad No 130, , 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 PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
Frequently Asked Questions
What is Sudem Gida Ic Ve Dis Tic Ltd.'s FDA import refusal history?
Sudem Gida Ic Ve Dis Tic Ltd. (FEI: 3004155064) has 2 FDA import refusal record(s) in our database, spanning from 8/25/2004 to 8/25/2004.
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. Sudem Gida Ic Ve Dis Tic Ltd.'s FEI number is 3004155064.
What types of violations has Sudem Gida Ic Ve Dis Tic Ltd. received?
Sudem Gida Ic Ve Dis Tic Ltd. 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 Sudem Gida Ic Ve Dis Tic Ltd. come from?
All FDA import refusal data for Sudem Gida Ic Ve Dis Tic Ltd. 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.