Wuhan Medfibers Technology Co.,Ltd
⚠️ Moderate Risk
FEI: 3012042520 • Wuhan, Hubei • CHINA
FEI Number
3012042520
Location
Wuhan, Hubei
Country
CHINAAddress
3rd Floor, Building 17, East Lake High-Tech Industrial Innovation Base, No. 9 Miaoshan Avenue; Jiangxia District, Wuhan, Hubei, 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.
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
Refusal History
Frequently Asked Questions
What is Wuhan Medfibers Technology Co.,Ltd's FDA import refusal history?
Wuhan Medfibers Technology Co.,Ltd (FEI: 3012042520) has 1 FDA import refusal record(s) in our database, spanning from 5/21/2019 to 5/21/2019.
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. Wuhan Medfibers Technology Co.,Ltd's FEI number is 3012042520.
What types of violations has Wuhan Medfibers Technology Co.,Ltd received?
Wuhan Medfibers Technology 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 Wuhan Medfibers Technology Co.,Ltd come from?
All FDA import refusal data for Wuhan Medfibers Technology 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.