ASSAMER KOZMETIK
⚠️ High Risk
FEI: 3031955020 • Mersin • TURKEY
FEI Number
3031955020
Location
Mersin
Country
TURKEYAddress
Palmiye Mah. 1211 Sk., Cevik Apt A Blok No: 3 B, Mersin, , Turkey
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/28/2025 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | Division of Southeast Imports (DSEI) | |
| 12/18/2024 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | Division of Southeast Imports (DSEI) | |
| 12/18/2024 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | Division of Southeast Imports (DSEI) | |
| 12/18/2024 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | Division of Southeast Imports (DSEI) | |
| 12/18/2024 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | Division of Southeast Imports (DSEI) | |
| 12/18/2024 | 86LPNACCESSORIES TO CONTACT LENSES - CLEANING AND WETTING AGENTS | Division of Southeast Imports (DSEI) | |
| 12/17/2024 | 86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ASSAMER KOZMETIK's FDA import refusal history?
ASSAMER KOZMETIK (FEI: 3031955020) has 7 FDA import refusal record(s) in our database, spanning from 12/17/2024 to 2/28/2025.
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. ASSAMER KOZMETIK's FEI number is 3031955020.
What types of violations has ASSAMER KOZMETIK received?
ASSAMER KOZMETIK has been cited for 5 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 ASSAMER KOZMETIK come from?
All FDA import refusal data for ASSAMER KOZMETIK 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.