Hui Yung Medicine Co., Ltd
✅ Low Risk
FEI: 3008601545 • Jiouru Township • TAIWAN
FEI Number
3008601545
Location
Jiouru Township
Country
TAIWANAddress
No. 51 Lane 46, Cingsheng St., HouJhuang Village, Jiouru Township, , Taiwan
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
Frequently Asked Questions
What is Hui Yung Medicine Co., Ltd's FDA import refusal history?
Hui Yung Medicine Co., Ltd (FEI: 3008601545) has 1 FDA import refusal record(s) in our database, spanning from 2/18/2011 to 2/18/2011.
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. Hui Yung Medicine Co., Ltd's FEI number is 3008601545.
What types of violations has Hui Yung Medicine Co., Ltd received?
Hui Yung Medicine Co., Ltd has been cited for 4 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 Hui Yung Medicine Co., Ltd come from?
All FDA import refusal data for Hui Yung Medicine 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.