Aksan Kozmetik Sanayi Ve Ticaret A.S.
⚠️ Moderate Risk
FEI: 3014725732 • Arnavutkoy, Istanbul • TURKEY
FEI Number
3014725732
Location
Arnavutkoy, Istanbul
Country
TURKEYAddress
No.23-25a Deliklikaya Mahallesi, Kisikli Caddesi, Arnavutkoy, 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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/19/2021 | 62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 12/30/2020 | 62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 12/30/2020 | 62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Aksan Kozmetik Sanayi Ve Ticaret A.S.'s FDA import refusal history?
Aksan Kozmetik Sanayi Ve Ticaret A.S. (FEI: 3014725732) has 3 FDA import refusal record(s) in our database, spanning from 12/30/2020 to 1/19/2021.
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. Aksan Kozmetik Sanayi Ve Ticaret A.S.'s FEI number is 3014725732.
What types of violations has Aksan Kozmetik Sanayi Ve Ticaret A.S. received?
Aksan Kozmetik Sanayi Ve Ticaret A.S. 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 Aksan Kozmetik Sanayi Ve Ticaret A.S. come from?
All FDA import refusal data for Aksan Kozmetik Sanayi Ve Ticaret A.S. 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.