Cosmolive Kozmetik Sanayi Ve Ticaret A.S.
⚠️ Moderate Risk
FEI: 3016777559 • Cigli, Izmir • TURKEY
FEI Number
3016777559
Location
Cigli, Izmir
Country
TURKEYAddress
No.8 Aosb Mahallesi, Mustafa Kemal Ataturk Bulvari, Cigli, 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
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
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.
Refusal History
Frequently Asked Questions
What is Cosmolive Kozmetik Sanayi Ve Ticaret A.S.'s FDA import refusal history?
Cosmolive Kozmetik Sanayi Ve Ticaret A.S. (FEI: 3016777559) has 2 FDA import refusal record(s) in our database, spanning from 3/20/2024 to 4/4/2024.
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. Cosmolive Kozmetik Sanayi Ve Ticaret A.S.'s FEI number is 3016777559.
What types of violations has Cosmolive Kozmetik Sanayi Ve Ticaret A.S. received?
Cosmolive Kozmetik Sanayi Ve Ticaret A.S. has been cited for 3 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 Cosmolive Kozmetik Sanayi Ve Ticaret A.S. come from?
All FDA import refusal data for Cosmolive 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.