Jianhe Medical Articles Company Ltd
⚠️ Moderate Risk
FEI: 3009126358 • Suzhou, Jiangsu • CHINA
FEI Number
3009126358
Location
Suzhou, Jiangsu
Country
CHINAAddress
86 Suli Road, Changqiaozhen Wuzhong, Suzhou, Jiangsu, China
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
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.
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 Jianhe Medical Articles Company Ltd's FDA import refusal history?
Jianhe Medical Articles Company Ltd (FEI: 3009126358) has 1 FDA import refusal record(s) in our database, spanning from 1/4/2018 to 1/4/2018.
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. Jianhe Medical Articles Company Ltd's FEI number is 3009126358.
What types of violations has Jianhe Medical Articles Company Ltd received?
Jianhe Medical Articles Company 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 Jianhe Medical Articles Company Ltd come from?
All FDA import refusal data for Jianhe Medical Articles Company 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.