Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S.
🚨 Critical Risk
FEI: 3004135088 • Cekmekoy, Istanbul (Anatolia) • TURKEY
FEI
FEI Number
3004135088
📍
Location
Cekmekoy, Istanbul (Anatolia)
🇹🇷
Country
TURKEY🏢
Address
32 Omerli Mahallesi, Uran Caddesi, Cekmekoy, Istanbul (Anatolia), Turkey
Critical Risk
FDA Import Risk Assessment
80.6
LowModerateHighCritical
This firm has an extensive history of FDA import refusals with severe violations.
Statistics
78
Total Refusals
4
Unique Violations
6/14/2025
Latest Refusal
8/4/2023
Earliest Refusal
Score Breakdown
Violation Severity
79.5×40%
Refusal Volume
70.3×30%
Recency
88.5×20%
Frequency
100.0×10%
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
2774×
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).
753×
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).
1181×
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).
4821×
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/14/2025 | 53LF03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/14/2025 | 53LF03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 6/14/2025 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/17/2025 | 29AYI09SOFT DRINK, OTHER FRUIT FLAVORED, NONCARBONATED | 482NUTRIT LBL | Division of Southeast Imports (DSEI) |
| 3/14/2024 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 3/14/2024 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/13/2024 | 65LAL11TITANIUM DIOXIDE (PROTECTANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/13/2024 | 65LAL11TITANIUM DIOXIDE (PROTECTANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/12/2024 | 65LAL11TITANIUM DIOXIDE (PROTECTANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/12/2024 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/12/2024 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/12/2024 | 53LF03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/12/2024 | 53LF03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/12/2024 | 53LF03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/12/2024 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 2/12/2024 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/25/2024 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/9/2024 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/9/2024 | 66PBY16OCTOCRYLENE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/5/2024 | 65LAL11TITANIUM DIOXIDE (PROTECTANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/5/2024 | 65LAL11TITANIUM DIOXIDE (PROTECTANT) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/4/2024 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/4/2024 | 66PBY14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/18/2023 | 66PBY14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 12/18/2023 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/29/2023 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/29/2023 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/29/2023 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/29/2023 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/29/2023 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/29/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/29/2023 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 11/2/2023 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 11/2/2023 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/31/2023 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/31/2023 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/20/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/20/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/20/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/20/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/20/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/20/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/16/2023 | 66PBY14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 10/3/2023 | 63RAJ04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 9/22/2023 | 64XAL06SALICYLIC ACID (KERATOLYTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 9/22/2023 | 64XAL06SALICYLIC ACID (KERATOLYTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 9/22/2023 | 66PBY14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 9/22/2023 | 66PBY14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 9/22/2023 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 9/22/2023 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 9/22/2023 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 9/1/2023 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/17/2023 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/9/2023 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/9/2023 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/9/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/9/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 64XAL06SALICYLIC ACID (KERATOLYTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 64XAL06SALICYLIC ACID (KERATOLYTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 66PBY14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 66PBY14OCTINOXATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/4/2023 | 66PBY05HOMOSALATE (ULTRAVIOLET SCREEN/SUNSCREEN) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S.'s FDA import refusal history?
Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S. (FEI: 3004135088) has 78 FDA import refusal record(s) in our database, spanning from 8/4/2023 to 6/14/2025.
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. Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S.'s FEI number is 3004135088.
What types of violations has Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S. received?
Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S. 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 Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S. come from?
All FDA import refusal data for Tan-Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret A.S. 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.