LONGNAN RENZHONG MEDICAL EQUIPMENT CO.LTD
⚠️ Moderate Risk
FEI: 3016869759 • Jiangxi • CHINA
FEI Number
3016869759
Location
Jiangxi
Country
CHINAAddress
Industry Technology City,Longnan Dev Zone, , Jiangxi, , 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
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is LONGNAN RENZHONG MEDICAL EQUIPMENT CO.LTD's FDA import refusal history?
LONGNAN RENZHONG MEDICAL EQUIPMENT CO.LTD (FEI: 3016869759) has 1 FDA import refusal record(s) in our database, spanning from 7/2/2020 to 7/2/2020.
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. LONGNAN RENZHONG MEDICAL EQUIPMENT CO.LTD's FEI number is 3016869759.
What types of violations has LONGNAN RENZHONG MEDICAL EQUIPMENT CO.LTD received?
LONGNAN RENZHONG MEDICAL EQUIPMENT 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 LONGNAN RENZHONG MEDICAL EQUIPMENT CO.LTD come from?
All FDA import refusal data for LONGNAN RENZHONG MEDICAL EQUIPMENT 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.