Sunbay Supplies China Co Ltd
✅ Low Risk
FEI: 3007343979 • Jinan, Shandong • CHINA
FEI Number
3007343979
Location
Jinan, Shandong
Country
CHINAAddress
1 Hui You Rd Ming Shui Cha Jiu, Zhangqiu, Jinan, Shandong, 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 |
|---|---|---|---|
| 9/22/2010 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Sunbay Supplies China Co Ltd's FDA import refusal history?
Sunbay Supplies China Co Ltd (FEI: 3007343979) has 1 FDA import refusal record(s) in our database, spanning from 9/22/2010 to 9/22/2010.
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. Sunbay Supplies China Co Ltd's FEI number is 3007343979.
What types of violations has Sunbay Supplies China Co Ltd received?
Sunbay Supplies China Co 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 Sunbay Supplies China Co Ltd come from?
All FDA import refusal data for Sunbay Supplies China 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.