NINGBO BELLAVIE ELECTRIC APPLIANCE CO.,LTD
⚠️ Moderate Risk
FEI: 3022588961 • Ningbo, Zhejiang • CHINA
FEI Number
3022588961
Location
Ningbo, Zhejiang
Country
CHINAAddress
Gaoqiao Town, Qiyang Village; Haishu District, 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
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/29/2024 | 89IRTPAD, HEATING, POWERED | Division of West Coast Imports (DWCI) | |
| 5/1/2023 | 89IRTPAD, HEATING, POWERED | 479DV QUALITY | Division of Northeast Imports (DNEI) |
| 10/17/2019 | 89IRTPAD, HEATING, POWERED | 118NOT LISTED | Division of Southwest Imports (DSWI) |
| 9/20/2019 | 89IRTPAD, HEATING, POWERED | 341REGISTERED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is NINGBO BELLAVIE ELECTRIC APPLIANCE CO.,LTD's FDA import refusal history?
NINGBO BELLAVIE ELECTRIC APPLIANCE CO.,LTD (FEI: 3022588961) has 4 FDA import refusal record(s) in our database, spanning from 9/20/2019 to 6/29/2024.
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 BELLAVIE ELECTRIC APPLIANCE CO.,LTD's FEI number is 3022588961.
What types of violations has NINGBO BELLAVIE ELECTRIC APPLIANCE CO.,LTD received?
NINGBO BELLAVIE ELECTRIC APPLIANCE CO.,LTD has been cited for 5 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 BELLAVIE ELECTRIC APPLIANCE CO.,LTD come from?
All FDA import refusal data for NINGBO BELLAVIE ELECTRIC APPLIANCE 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.