Cellumed Co Ltd
✅ Low Risk
FEI: 3010197259 • Seoul • SOUTH KOREA
FEI Number
3010197259
Location
Seoul
Country
SOUTH KOREAAddress
402 Acetechno Tower 9th 345-30, , Seoul, , South Korea
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
Frequently Asked Questions
What is Cellumed Co Ltd's FDA import refusal history?
Cellumed Co Ltd (FEI: 3010197259) has 1 FDA import refusal record(s) in our database, spanning from 8/2/2018 to 8/2/2018.
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. Cellumed Co Ltd's FEI number is 3010197259.
What types of violations has Cellumed Co Ltd received?
Cellumed Co Ltd has been cited for 2 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 Cellumed Co Ltd come from?
All FDA import refusal data for Cellumed 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.