WUXI VISION PRO LTD
⚠️ Moderate Risk
FEI: 3014002883 • Wuxi, Jiangsu • CHINA
FEI Number
3014002883
Location
Wuxi, Jiangsu
Country
CHINAAddress
Buliging 17, Software Park Floor 1, 29 Lianze Road, Wuxi, Jiangsu, 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
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/19/2019 | 86HQLLENS, INTRAOCULAR | 237NO PMA | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is WUXI VISION PRO LTD's FDA import refusal history?
WUXI VISION PRO LTD (FEI: 3014002883) has 1 FDA import refusal record(s) in our database, spanning from 4/19/2019 to 4/19/2019.
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. WUXI VISION PRO LTD's FEI number is 3014002883.
What types of violations has WUXI VISION PRO LTD received?
WUXI VISION PRO LTD has been cited for 1 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 WUXI VISION PRO LTD come from?
All FDA import refusal data for WUXI VISION PRO 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.