Tura International Ltd
⚠️ High Risk
FEI: 3001385589 • London • UNITED KINGDOM
FEI Number
3001385589
Location
London
Country
UNITED KINGDOMAddress
Unknown, , London, , United Kingdom
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).
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/29/2025 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/29/2012 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 8/5/2008 | 66PBJ09PADIMATE O (ULTRAVIOLET SCREEN/SUNSCREEN) | Los Angeles District Office (LOS-DO) | |
| 6/17/2002 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Minneapolis District Office (MIN-DO) | |
| 1/4/2002 | 66BIY99STIMULANT N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 1/4/2002 | 66BIY99STIMULANT N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Tura International Ltd's FDA import refusal history?
Tura International Ltd (FEI: 3001385589) has 6 FDA import refusal record(s) in our database, spanning from 1/4/2002 to 4/29/2025.
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. Tura International Ltd's FEI number is 3001385589.
What types of violations has Tura International Ltd received?
Tura International Ltd has been cited for 6 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 Tura International Ltd come from?
All FDA import refusal data for Tura International Ltd 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.