BAHADIR TIBBI ALET CIHAZ VE INSAAT MAKINA SAN. VE TIC. AS
⚠️ Moderate Risk
FEI: 3003717943 • Samsun, Samsun • TURKEY
FEI Number
3003717943
Location
Samsun, Samsun
Country
TURKEYAddress
Sabanoglu Osb Mahallesi Vali M.Erdogan Cebeci Bulvari No:29/1 Tekkekoy, , Samsun, Samsun, 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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/25/2019 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) | |
| 10/25/2019 | 85HDNDILATOR, CERVICAL, EXPANDABLE | Division of Southeast Imports (DSEI) | |
| 10/25/2019 | 79FZXGUIDE, SURGICAL, INSTRUMENT | Division of Southeast Imports (DSEI) | |
| 10/25/2019 | 79GADRETRACTOR, SURGICAL, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) | |
| 10/25/2019 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) | |
| 10/25/2019 | 79GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is BAHADIR TIBBI ALET CIHAZ VE INSAAT MAKINA SAN. VE TIC. AS's FDA import refusal history?
BAHADIR TIBBI ALET CIHAZ VE INSAAT MAKINA SAN. VE TIC. AS (FEI: 3003717943) has 6 FDA import refusal record(s) in our database, spanning from 10/25/2019 to 10/25/2019.
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. BAHADIR TIBBI ALET CIHAZ VE INSAAT MAKINA SAN. VE TIC. AS's FEI number is 3003717943.
What types of violations has BAHADIR TIBBI ALET CIHAZ VE INSAAT MAKINA SAN. VE TIC. AS received?
BAHADIR TIBBI ALET CIHAZ VE INSAAT MAKINA SAN. VE TIC. AS has been cited for 2 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 BAHADIR TIBBI ALET CIHAZ VE INSAAT MAKINA SAN. VE TIC. AS come from?
All FDA import refusal data for BAHADIR TIBBI ALET CIHAZ VE INSAAT MAKINA SAN. VE TIC. AS 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.