Charmzone Corporation, Ltd.
⚠️ High Risk
FEI: 3000086069 • Gangnam, Seoul • SOUTH KOREA
FEI Number
3000086069
Location
Gangnam, Seoul
Country
SOUTH KOREAAddress
106-16 Charmzone Bldg., Chungdamng, Gangnam, Seoul, South Korea
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/9/2016 | 53CC99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/9/2016 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/9/2016 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/9/2016 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/9/2016 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/9/2016 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/9/2016 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/9/2016 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/9/2016 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/9/2016 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/9/2016 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 5/9/2016 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/15/2014 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 6/27/2013 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
| 7/28/2009 | 66PAY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | San Francisco District Office (SAN-DO) | |
| 7/28/2009 | 66PAY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | San Francisco District Office (SAN-DO) | |
| 2/27/2006 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 2/27/2006 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 10/25/2005 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 1/20/2005 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/7/2004 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 5/13/2003 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 3/26/2003 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
| 3/26/2003 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
| 3/26/2003 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Charmzone Corporation, Ltd.'s FDA import refusal history?
Charmzone Corporation, Ltd. (FEI: 3000086069) has 25 FDA import refusal record(s) in our database, spanning from 3/26/2003 to 5/9/2016.
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. Charmzone Corporation, Ltd.'s FEI number is 3000086069.
What types of violations has Charmzone Corporation, Ltd. received?
Charmzone Corporation, Ltd. has been cited for 7 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 Charmzone Corporation, Ltd. come from?
All FDA import refusal data for Charmzone Corporation, 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.