I-Sens, Inc.
⚠️ Moderate Risk
FEI: 3005621222 • Seoul • SOUTH KOREA
FEI Number
3005621222
Location
Seoul
Country
SOUTH KOREAAddress
Gil, Seocho, 28 43, Banpo-Daero, 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
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).
Refusal History
Frequently Asked Questions
What is I-Sens, Inc.'s FDA import refusal history?
I-Sens, Inc. (FEI: 3005621222) has 3 FDA import refusal record(s) in our database, spanning from 12/6/2019 to 12/6/2019.
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. I-Sens, Inc.'s FEI number is 3005621222.
What types of violations has I-Sens, Inc. received?
I-Sens, Inc. has been cited for 1 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 I-Sens, Inc. come from?
All FDA import refusal data for I-Sens, 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.