MAYK COSMETICS
⚠️ Moderate Risk
FEI: 3012823671 • Goyangsi Ilsandong-gu, Gyeonggi-do • SOUTH KOREA
FEI Number
3012823671
Location
Goyangsi Ilsandong-gu, Gyeonggi-do
Country
SOUTH KOREAAddress
Ndong-Gu, Goyang-S, 19 Jeongbalsan-ro, Goyangsi Ilsandong-gu, Gyeonggi-do, 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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/7/2017 | 65CBL01ADENOSINE PHOSPHATE (NUTRIENT/TONIC) | Division of West Coast Imports (DWCI) | |
| 3/7/2017 | 65GBJ99PIGMENTATION AGENT N.E.C. | Division of West Coast Imports (DWCI) | |
| 3/7/2017 | 66PDR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | Division of West Coast Imports (DWCI) | |
| 3/7/2017 | 66PDR99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is MAYK COSMETICS's FDA import refusal history?
MAYK COSMETICS (FEI: 3012823671) has 4 FDA import refusal record(s) in our database, spanning from 3/7/2017 to 3/7/2017.
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. MAYK COSMETICS's FEI number is 3012823671.
What types of violations has MAYK COSMETICS received?
MAYK COSMETICS has been cited for 3 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 MAYK COSMETICS come from?
All FDA import refusal data for MAYK COSMETICS 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.