NINGBO YINZHOU FIRST ECHO INTERNATIONAL TRADING CO., LTD
⚠️ Moderate Risk
FEI: 3009718665 • Ningbo, Zhejiang • CHINA
FEI Number
3009718665
Location
Ningbo, Zhejiang
Country
CHINAAddress
Fl. 3, NO. 255. Changshou Rd; Yinzhou, Ningbo, Zhejiang, 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 |
|---|---|---|---|
| 6/13/2014 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 237NO PMA | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is NINGBO YINZHOU FIRST ECHO INTERNATIONAL TRADING CO., LTD's FDA import refusal history?
NINGBO YINZHOU FIRST ECHO INTERNATIONAL TRADING CO., LTD (FEI: 3009718665) has 1 FDA import refusal record(s) in our database, spanning from 6/13/2014 to 6/13/2014.
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 YINZHOU FIRST ECHO INTERNATIONAL TRADING CO., LTD's FEI number is 3009718665.
What types of violations has NINGBO YINZHOU FIRST ECHO INTERNATIONAL TRADING CO., LTD received?
NINGBO YINZHOU FIRST ECHO INTERNATIONAL TRADING 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 NINGBO YINZHOU FIRST ECHO INTERNATIONAL TRADING CO., LTD come from?
All FDA import refusal data for NINGBO YINZHOU FIRST ECHO INTERNATIONAL TRADING 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.