Hang Yang Chemistry Co Ltd
⚠️ Moderate Risk
FEI: 3003476047 • Kaohsiung Taiwan • TAIWAN
FEI Number
3003476047
Location
Kaohsiung Taiwan
Country
TAIWANAddress
No 5 Lane 439, Anjau Rd., Yanchau Shiang, , Kaohsiung Taiwan, , Taiwan
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
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).
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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 Hang Yang Chemistry Co Ltd's FDA import refusal history?
Hang Yang Chemistry Co Ltd (FEI: 3003476047) has 2 FDA import refusal record(s) in our database, spanning from 10/22/2003 to 5/13/2006.
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. Hang Yang Chemistry Co Ltd's FEI number is 3003476047.
What types of violations has Hang Yang Chemistry Co Ltd received?
Hang Yang Chemistry 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 Hang Yang Chemistry Co Ltd come from?
All FDA import refusal data for Hang Yang Chemistry 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.