HONG KONG XIMIVOGUE TRADING CO,LTD
⚠️ Moderate Risk
FEI: 3015727238 • Kwai Chung N.T. • CHINA
FEI Number
3015727238
Location
Kwai Chung N.T.
Country
CHINAAddress
Room 06 Blk A23/F Hoverind Bldg 26-38 Kwai, Cheong Rd, Kwai Chung N.T., , 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 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 |
|---|---|---|---|
| 12/26/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 12/26/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 12/6/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HONG KONG XIMIVOGUE TRADING CO,LTD's FDA import refusal history?
HONG KONG XIMIVOGUE TRADING CO,LTD (FEI: 3015727238) has 3 FDA import refusal record(s) in our database, spanning from 12/6/2019 to 12/26/2019.
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. HONG KONG XIMIVOGUE TRADING CO,LTD's FEI number is 3015727238.
What types of violations has HONG KONG XIMIVOGUE TRADING CO,LTD received?
HONG KONG XIMIVOGUE TRADING CO,LTD has been cited for 3 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 HONG KONG XIMIVOGUE TRADING CO,LTD come from?
All FDA import refusal data for HONG KONG XIMIVOGUE 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.