Ningbo Home Solution Corp., Ltd.
⚠️ Moderate Risk
FEI: 3005159567 • Ningbo, Zhejiang • CHINA
FEI Number
3005159567
Location
Ningbo, Zhejiang
Country
CHINAAddress
Xinjinsui Mansion F 11, 128 North Jiefang Road, 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
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).
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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/5/2017 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | Division of Northern Border Imports (DNBI) | |
| 7/24/2014 | 80FQMBANDAGE, ELASTIC | 341REGISTERED | Division of Northeast Imports (DNEI) |
| 3/30/2011 | 76EFWTOOTHBRUSH, MANUAL | Seattle District Office (SEA-DO) | |
| 7/17/2008 | 89ITGBANDAGE, CAST | 118NOT LISTED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Ningbo Home Solution Corp., Ltd.'s FDA import refusal history?
Ningbo Home Solution Corp., Ltd. (FEI: 3005159567) has 4 FDA import refusal record(s) in our database, spanning from 7/17/2008 to 6/5/2017.
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. Ningbo Home Solution Corp., Ltd.'s FEI number is 3005159567.
What types of violations has Ningbo Home Solution Corp., Ltd. received?
Ningbo Home Solution Corp., Ltd. has been cited for 4 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 Home Solution Corp., Ltd. come from?
All FDA import refusal data for Ningbo Home Solution Corp., 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.