Celluon Inc.
⚠️ Moderate Risk
FEI: 3009409725 • Seoul • SOUTH KOREA
FEI Number
3009409725
Location
Seoul
Country
SOUTH KOREAAddress
Ace High-End Tower 1101,, 235-2, Guro-dong, Guro-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
NO TAG
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 to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
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.
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/28/2013 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Los Angeles District Office (LOS-DO) | |
| 1/28/2013 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Los Angeles District Office (LOS-DO) | |
| 1/28/2013 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Celluon Inc.'s FDA import refusal history?
Celluon Inc. (FEI: 3009409725) has 3 FDA import refusal record(s) in our database, spanning from 1/28/2013 to 1/28/2013.
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. Celluon Inc.'s FEI number is 3009409725.
What types of violations has Celluon Inc. received?
Celluon Inc. has been cited for 4 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 Celluon Inc. come from?
All FDA import refusal data for Celluon Inc. 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.