SHENZHEN FRED TRADE CO LTD
✅ Low Risk
FEI: 3012866437 • Baoan • CHINA
FEI Number
3012866437
Location
Baoan
Country
CHINAAddress
9F Huafeng First Scienc, District, Shenz, Baoan, , 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 |
|---|---|---|---|
| 2/24/2017 | 76ECIBAND, ELASTIC, ORTHODONTIC | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is SHENZHEN FRED TRADE CO LTD's FDA import refusal history?
SHENZHEN FRED TRADE CO LTD (FEI: 3012866437) has 1 FDA import refusal record(s) in our database, spanning from 2/24/2017 to 2/24/2017.
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 FRED TRADE CO LTD's FEI number is 3012866437.
What types of violations has SHENZHEN FRED TRADE CO LTD received?
SHENZHEN FRED TRADE 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 SHENZHEN FRED TRADE CO LTD come from?
All FDA import refusal data for SHENZHEN FRED TRADE 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.