SIMAY UVEZ
⚠️ Moderate Risk
FEI: 3018247047 • Esenler, Istanbul • TURKEY
FEI Number
3018247047
Location
Esenler, Istanbul
Country
TURKEYAddress
Orucreis Mah., Tekstilkent Cadde No 12, Esenler, 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
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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/8/2022 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/3/2021 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Southeast Imports (DSEI) | |
| 11/29/2021 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 84RX DEVICE | Division of Southeast Imports (DSEI) |
| 6/7/2021 | 80KZHINTRODUCER, SYRINGE NEEDLE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SIMAY UVEZ's FDA import refusal history?
SIMAY UVEZ (FEI: 3018247047) has 4 FDA import refusal record(s) in our database, spanning from 6/7/2021 to 3/8/2022.
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. SIMAY UVEZ's FEI number is 3018247047.
What types of violations has SIMAY UVEZ received?
SIMAY UVEZ 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 SIMAY UVEZ come from?
All FDA import refusal data for SIMAY UVEZ 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.