Shenzhen Willow Handicraft Articles
⚠️ Moderate Risk
FEI: 3007542903 • Shenzhen • CHINA
FEI Number
3007542903
Location
Shenzhen
Country
CHINAAddress
Industrial Estate, Nanshan District, , Shenzhen, , 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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).
Refusal History
Frequently Asked Questions
What is Shenzhen Willow Handicraft Articles's FDA import refusal history?
Shenzhen Willow Handicraft Articles (FEI: 3007542903) has 2 FDA import refusal record(s) in our database, spanning from 10/22/2009 to 1/13/2010.
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. Shenzhen Willow Handicraft Articles's FEI number is 3007542903.
What types of violations has Shenzhen Willow Handicraft Articles received?
Shenzhen Willow Handicraft Articles 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 Shenzhen Willow Handicraft Articles come from?
All FDA import refusal data for Shenzhen Willow Handicraft Articles 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.