TIS SANAYI DIS TICARET AS
⚠️ Moderate Risk
FEI: 3013397154 • Istanbul • TURKEY
FEI Number
3013397154
Location
Istanbul
Country
TURKEYAddress
Sutlucesme Mah Imrahorcad No 36/4 Beyoglu, , 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
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.
NOCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it appears to be a nonprescription drug that is misbranded within the meaning of Section 502(x) of the FD&C Act in that the product label fails to bear a domestic address or phone number through which the responsible person may receive a report of a serious adverse event with such drug.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/29/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 12/29/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 12/29/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 12/29/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 12/29/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 12/29/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 12/29/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 12/29/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 12/29/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 12/29/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is TIS SANAYI DIS TICARET AS's FDA import refusal history?
TIS SANAYI DIS TICARET AS (FEI: 3013397154) has 10 FDA import refusal record(s) in our database, spanning from 12/29/2020 to 12/29/2020.
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. TIS SANAYI DIS TICARET AS's FEI number is 3013397154.
What types of violations has TIS SANAYI DIS TICARET AS received?
TIS SANAYI DIS TICARET 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 TIS SANAYI DIS TICARET AS come from?
All FDA import refusal data for TIS SANAYI DIS TICARET 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.