Th Leader Expo Llc
⚠️ Moderate Risk
FEI: 3010032948 • Moscow, Moscow g • RUSSIA
FEI Number
3010032948
Location
Moscow, Moscow g
Country
RUSSIAAddress
Novoyasenevskiy tup 2, , CORPUS, Moscow, Moscow g, Russia
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
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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/24/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 12/10/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northeast Imports (DNEI) |
| 12/10/2014 | 66PAS99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northeast Imports (DNEI) | |
| 12/10/2014 | 66PCS99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northeast Imports (DNEI) | |
| 12/10/2014 | 66PCS99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northeast Imports (DNEI) | |
| 12/10/2014 | 66PAS99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northeast Imports (DNEI) | |
| 12/10/2014 | 66PAS99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of Northeast Imports (DNEI) | |
| 10/2/2014 | 30AFT05BEVERAGE BASE, PIT FRUIT | 11UNSAFE COL | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Th Leader Expo Llc's FDA import refusal history?
Th Leader Expo Llc (FEI: 3010032948) has 8 FDA import refusal record(s) in our database, spanning from 10/2/2014 to 12/24/2014.
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. Th Leader Expo Llc's FEI number is 3010032948.
What types of violations has Th Leader Expo Llc received?
Th Leader Expo Llc has been cited for 11 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 Th Leader Expo Llc come from?
All FDA import refusal data for Th Leader Expo Llc 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.