YIWU JXST TRADING CO. LTD
⚠️ Moderate Risk
FEI: 3017085533 • Yiwu • CHINA
FEI Number
3017085533
Location
Yiwu
Country
CHINAAddress
St Building 1st Floor 47, Beiyuan Road; Liuqin 2nd Dist, Yiwu, , 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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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.
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 |
|---|---|---|---|
| 1/6/2021 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of West Coast Imports (DWCI) | |
| 10/30/2020 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is YIWU JXST TRADING CO. LTD's FDA import refusal history?
YIWU JXST TRADING CO. LTD (FEI: 3017085533) has 2 FDA import refusal record(s) in our database, spanning from 10/30/2020 to 1/6/2021.
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. YIWU JXST TRADING CO. LTD's FEI number is 3017085533.
What types of violations has YIWU JXST TRADING CO. LTD received?
YIWU JXST TRADING 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 YIWU JXST TRADING CO. LTD come from?
All FDA import refusal data for YIWU JXST 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.