ONE MORE MEDIKAL SANAYI VE DIS TICARET LIMITED SIRKETI
⚠️ Moderate Risk
FEI: 3017942845 • Istanbul, ISTANBUL • TURKEY
FEI Number
3017942845
Location
Istanbul, ISTANBUL
Country
TURKEYAddress
Namik Kemal Mahallesi 171. Sokak Aktivitem Plaza No: 13/4 Esenyurt, , Istanbul, 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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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
Frequently Asked Questions
What is ONE MORE MEDIKAL SANAYI VE DIS TICARET LIMITED SIRKETI's FDA import refusal history?
ONE MORE MEDIKAL SANAYI VE DIS TICARET LIMITED SIRKETI (FEI: 3017942845) has 1 FDA import refusal record(s) in our database, spanning from 2/6/2023 to 2/6/2023.
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. ONE MORE MEDIKAL SANAYI VE DIS TICARET LIMITED SIRKETI's FEI number is 3017942845.
What types of violations has ONE MORE MEDIKAL SANAYI VE DIS TICARET LIMITED SIRKETI received?
ONE MORE MEDIKAL SANAYI VE DIS TICARET LIMITED SIRKETI 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 ONE MORE MEDIKAL SANAYI VE DIS TICARET LIMITED SIRKETI come from?
All FDA import refusal data for ONE MORE MEDIKAL SANAYI VE DIS TICARET LIMITED SIRKETI 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.