Viss Beauty(Narian Global)
⚠️ Moderate Risk
FEI: 3009659725 • Seoul, Seoul • SOUTH KOREA
FEI Number
3009659725
Location
Seoul, Seoul
Country
SOUTH KOREAAddress
Hwagok 4 Dong 212, , Seoul, 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
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).
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.
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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/22/2016 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Division of Southeast Imports (DSEI) | |
| 11/22/2016 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Division of Southeast Imports (DSEI) | |
| 3/7/2013 | 79NRJULTRASOUND, SKIN PERMEATION | Los Angeles District Office (LOS-DO) | |
| 3/6/2013 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Cincinnati District Office (CIN-DO) | |
| 1/8/2013 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Los Angeles District Office (LOS-DO) | |
| 9/25/2012 | 79MWYSYSTEM, MICROWAVE, HAIR REMOVAL | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Viss Beauty(Narian Global)'s FDA import refusal history?
Viss Beauty(Narian Global) (FEI: 3009659725) has 6 FDA import refusal record(s) in our database, spanning from 9/25/2012 to 11/22/2016.
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. Viss Beauty(Narian Global)'s FEI number is 3009659725.
What types of violations has Viss Beauty(Narian Global) received?
Viss Beauty(Narian Global) 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 Viss Beauty(Narian Global) come from?
All FDA import refusal data for Viss Beauty(Narian Global) 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.