NOVOS TIBBI CIHAZLAR SAN TIC
⚠️ Moderate Risk
FEI: 3013673963 • Ankara • TURKEY
FEI Number
3013673963
Location
Ankara
Country
TURKEYAddress
Uzay Cagi Caddesi 82, , Ankara, , 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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/15/2017 | 73BTLVENTILATOR, EMERGENCY, POWERED (RESUSCITATOR) | Division of Southeast Imports (DSEI) | |
| 8/15/2017 | 80LBIUNIT, NEONATAL PHOTOTHERAPY | Division of Southeast Imports (DSEI) | |
| 8/15/2017 | 80FMTWARMER, INFANT RADIANT | Division of Southeast Imports (DSEI) | |
| 8/15/2017 | 80FMZINCUBATOR, NEONATAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is NOVOS TIBBI CIHAZLAR SAN TIC's FDA import refusal history?
NOVOS TIBBI CIHAZLAR SAN TIC (FEI: 3013673963) has 4 FDA import refusal record(s) in our database, spanning from 8/15/2017 to 8/15/2017.
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. NOVOS TIBBI CIHAZLAR SAN TIC's FEI number is 3013673963.
What types of violations has NOVOS TIBBI CIHAZLAR SAN TIC received?
NOVOS TIBBI CIHAZLAR SAN TIC 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 NOVOS TIBBI CIHAZLAR SAN TIC come from?
All FDA import refusal data for NOVOS TIBBI CIHAZLAR SAN TIC 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.