Ningbo Skyland Group Ltd
✅ Low Risk
FEI: 1000385135 • Ningbo • CHINA
FEI Number
1000385135
Location
Ningbo
Country
CHINAAddress
93 East Zhongshan Road, 9-14 Flr, Ningbo, , China
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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/26/2008 | 85LQTDOPPLER ULTRASOUND FOR FETAL EVALUATION | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Ningbo Skyland Group Ltd's FDA import refusal history?
Ningbo Skyland Group Ltd (FEI: 1000385135) has 1 FDA import refusal record(s) in our database, spanning from 3/26/2008 to 3/26/2008.
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. Ningbo Skyland Group Ltd's FEI number is 1000385135.
What types of violations has Ningbo Skyland Group Ltd received?
Ningbo Skyland Group 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 Ningbo Skyland Group Ltd come from?
All FDA import refusal data for Ningbo Skyland Group 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.