Tanalize Kozmetik Ve Temizlik
⚠️ Moderate Risk
FEI: 3004196619 • Istanbul • TURKEY
FEI Number
3004196619
Location
Istanbul
Country
TURKEYAddress
Omerli Beldesi,fabrikalar Yolu No.43, , 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
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(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
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).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/29/2019 | 53IG99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/14/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 6/14/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 6/14/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 6/14/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 6/14/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 6/14/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 6/14/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/19/2007 | 62WBL99ASTRINGENT/ANTI-PERSPIRANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/19/2007 | 63RBI06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/19/2007 | 63RBI06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/19/2007 | 63RBI06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Tanalize Kozmetik Ve Temizlik's FDA import refusal history?
Tanalize Kozmetik Ve Temizlik (FEI: 3004196619) has 12 FDA import refusal record(s) in our database, spanning from 10/19/2007 to 3/29/2019.
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. Tanalize Kozmetik Ve Temizlik's FEI number is 3004196619.
What types of violations has Tanalize Kozmetik Ve Temizlik received?
Tanalize Kozmetik Ve Temizlik has been cited for 4 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 Tanalize Kozmetik Ve Temizlik come from?
All FDA import refusal data for Tanalize Kozmetik Ve Temizlik 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.