Mycosmetic Co., Ltd.
⚠️ Moderate Risk
FEI: 3003514597 • Seoul • SOUTH KOREA
FEI Number
3003514597
Location
Seoul
Country
SOUTH KOREAAddress
14-2 Yeoido-Dong, Yeungdeungpo-Gu, , Seoul, , South Korea
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
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).
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).
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/18/2004 | 53CY03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 12/29/2003 | 53CY03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 12/29/2003 | 53CY03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 12/29/2003 | 53CY06MASCARA (EYE MAKEUP PREPARATIONS) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 10/2/2003 | 86LRXCASE, CONTACT LENS | Los Angeles District Office (LOS-DO) | |
| 10/2/2003 | 86LRXCASE, CONTACT LENS | Los Angeles District Office (LOS-DO) | |
| 5/1/2003 | 53CY03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
| 3/10/2003 | 86LRXCASE, CONTACT LENS | Los Angeles District Office (LOS-DO) | |
| 3/10/2003 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 2/13/2003 | 53CY03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Los Angeles District Office (LOS-DO) |
| 9/17/2002 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Mycosmetic Co., Ltd.'s FDA import refusal history?
Mycosmetic Co., Ltd. (FEI: 3003514597) has 11 FDA import refusal record(s) in our database, spanning from 9/17/2002 to 9/18/2004.
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. Mycosmetic Co., Ltd.'s FEI number is 3003514597.
What types of violations has Mycosmetic Co., Ltd. received?
Mycosmetic Co., Ltd. has been cited for 9 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 Mycosmetic Co., Ltd. come from?
All FDA import refusal data for Mycosmetic Co., 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.