Chabio&Diostech Co., Ltd
✅ Low Risk
FEI: 3009704119 • Seoul • SOUTH KOREA
FEI Number
3009704119
Location
Seoul
Country
SOUTH KOREAAddress
Eenhwang Bldg, 272-33, Nonhyun-Dong, , 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).
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
Frequently Asked Questions
What is Chabio&Diostech Co., Ltd's FDA import refusal history?
Chabio&Diostech Co., Ltd (FEI: 3009704119) has 1 FDA import refusal record(s) in our database, spanning from 9/5/2012 to 9/5/2012.
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. Chabio&Diostech Co., Ltd's FEI number is 3009704119.
What types of violations has Chabio&Diostech Co., Ltd received?
Chabio&Diostech Co., Ltd 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 Chabio&Diostech Co., Ltd come from?
All FDA import refusal data for Chabio&Diostech 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.