Wel Chun Enterprise Co., Ltd.
⚠️ Moderate Risk
FEI: 3003292652 • Tainan Hsien • TAIWAN
FEI Number
3003292652
Location
Tainan Hsien
Country
TAIWANAddress
No 47, Lane 53, Chung Jeng 5th St., , Yung-Kang City, Tainan Hsien, , 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
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
Frequently Asked Questions
What is Wel Chun Enterprise Co., Ltd.'s FDA import refusal history?
Wel Chun Enterprise Co., Ltd. (FEI: 3003292652) has 1 FDA import refusal record(s) in our database, spanning from 9/23/2010 to 9/23/2010.
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. Wel Chun Enterprise Co., Ltd.'s FEI number is 3003292652.
What types of violations has Wel Chun Enterprise Co., Ltd. received?
Wel Chun Enterprise 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 Wel Chun Enterprise Co., Ltd. come from?
All FDA import refusal data for Wel Chun Enterprise 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.