Kolmar Korea
⚠️ Moderate Risk
FEI: 3007056860 • Seocho, Seoul Teugbyeolsi • SOUTH KOREA
FEI Number
3007056860
Location
Seocho, Seoul Teugbyeolsi
Country
SOUTH KOREAAddress
1603-55 Seochong, , Seocho, Seoul Teugbyeolsi, 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
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.
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).
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).
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.
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 |
|---|---|---|---|
| 10/5/2023 | 66PBL18ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 10/5/2023 | 66PBL18ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 10/5/2023 | 66PBL18ZINC OXIDE (ULTRAVIOLET SCREEN/SUNSCREEN) | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
| 11/1/2011 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Kolmar Korea's FDA import refusal history?
Kolmar Korea (FEI: 3007056860) has 4 FDA import refusal record(s) in our database, spanning from 11/1/2011 to 10/5/2023.
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. Kolmar Korea's FEI number is 3007056860.
What types of violations has Kolmar Korea received?
Kolmar Korea 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 Kolmar Korea come from?
All FDA import refusal data for Kolmar Korea 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.