Korolev Pharm LLC
⚠️ Moderate Risk
FEI: 3009526484 • Korolyov City, Moscow • RUSSIA
FEI Number
3009526484
Location
Korolyov City, Moscow
Country
RUSSIAAddress
4 Pionerskaya Str, , Korolyov City, Moscow, 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/24/2017 | 60LDO99ANALGESIC, N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/24/2017 | 60LDO99ANALGESIC, N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/23/2017 | 61HBJ99ANTI-BACTERIAL, N.E.C. | Division of Northeast Imports (DNEI) | |
| 6/16/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 6/16/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 6/16/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 6/16/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 6/16/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 2/19/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 2/19/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 2/19/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 2/19/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 2/19/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 2/19/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 2/19/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 2/19/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
| 2/19/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Korolev Pharm LLC's FDA import refusal history?
Korolev Pharm LLC (FEI: 3009526484) has 17 FDA import refusal record(s) in our database, spanning from 2/19/2014 to 5/24/2017.
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. Korolev Pharm LLC's FEI number is 3009526484.
What types of violations has Korolev Pharm LLC received?
Korolev Pharm LLC has been cited for 5 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 Korolev Pharm LLC come from?
All FDA import refusal data for Korolev Pharm 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.