SORISO Co., Ltd
⚠️ Moderate Risk
FEI: 3016792479 • Gimje, Jeonrabug • SOUTH KOREA
FEI Number
3016792479
Location
Gimje, Jeonrabug
Country
SOUTH KOREAAddress
Rm A-302 195-20 Jayumuyeok-Gil, Baeksan-Myeon, Gimje, Jeonrabug, 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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
Frequently Asked Questions
What is SORISO Co., Ltd's FDA import refusal history?
SORISO Co., Ltd (FEI: 3016792479) has 1 FDA import refusal record(s) in our database, spanning from 8/20/2020 to 8/20/2020.
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. SORISO Co., Ltd's FEI number is 3016792479.
What types of violations has SORISO Co., Ltd received?
SORISO 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 SORISO Co., Ltd come from?
All FDA import refusal data for SORISO 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.