Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil
⚠️ High Risk
FEI: 3010166780 • Sokak Tuzla, Istanbul • TURKEY
FEI Number
3010166780
Location
Sokak Tuzla, Istanbul
Country
TURKEYAddress
Bolgesi Aydinli Sb Mahallesi, 6 12 Istanbul Endustri Veticaret Serbest, Sokak Tuzla, Istanbul, Turkey
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
LBLG ADVER
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/26/2024 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/26/2024 | 53ID02MOUTHWASHES AND BREATH FRESHENERS (LIQUIDS AND SPRAYS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/6/2021 | 61HAL05ZINC PYRITHIONE (ANTI-BACTERIAL) | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 8/18/2021 | 61FAL21CHLOROXYLENOL (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Division of Northeast Imports (DNEI) | |
| 7/2/2021 | 61HAL99ANTI-BACTERIAL, N.E.C. | 27DRUG GMPS | Division of Northeast Imports (DNEI) |
| 4/15/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 4/15/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 4/15/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 4/15/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 10/26/2011 | 61HBL99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/26/2011 | 61HBL99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/26/2011 | 61HBL99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/26/2011 | 61HBL99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/26/2011 | 61HBL99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 10/26/2011 | 61HBL99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil's FDA import refusal history?
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil (FEI: 3010166780) has 15 FDA import refusal record(s) in our database, spanning from 10/26/2011 to 2/26/2024.
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. Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil's FEI number is 3010166780.
What types of violations has Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil received?
Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil 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 Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil come from?
All FDA import refusal data for Delta Kozmetik Sanayi Ve Ticaret-Selim Yesil 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.