EXCELLENT ELITE INTERNATIONAL LTD
⚠️ Moderate Risk
FEI: 3017556485 • Tsim Sha Tsui, Kowloon • HONG KONG
FEI Number
3017556485
Location
Tsim Sha Tsui, Kowloon
Country
HONG KONGAddress
132 Nathan Road, , Tsim Sha Tsui, Kowloon, Hong Kong
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
TPLKUSSLLB
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(D) of the FD&C Act in that the label does not provide the statement "sale only allowed in the United States" and the tobacco product is not subject to any exemptions or variations.
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.
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
TPLACKFIRM
This article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(A) of the FD&C Act in that the label does not contain the name and place of business of the tobacco product manufacturer, packer or distributor.
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).
TPNICWARN
This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that appears to be misbranded under section 903(a)(7)(B) in that it is sold or distributed in violation of regulations prescribed under 906(d), namely its package fails to bear the required warning statement "WARNING: This product contains nicotine. Nicotine is an addictive chemical." Or if applicable the required statement "This product is made from tobacco."
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/23/2020 | 98LAA10ADVANCED PERSONAL VAPORIZER, KIT | Division of Southeast Imports (DSEI) | |
| 9/4/2020 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | Division of Northern Border Imports (DNBI) | |
| 6/29/2020 | 98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC | Division of Southeast Imports (DSEI) | |
| 2/20/2020 | 75LXGEQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is EXCELLENT ELITE INTERNATIONAL LTD's FDA import refusal history?
EXCELLENT ELITE INTERNATIONAL LTD (FEI: 3017556485) has 4 FDA import refusal record(s) in our database, spanning from 2/20/2020 to 12/23/2020.
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. EXCELLENT ELITE INTERNATIONAL LTD's FEI number is 3017556485.
What types of violations has EXCELLENT ELITE INTERNATIONAL LTD received?
EXCELLENT ELITE INTERNATIONAL LTD has been cited for 7 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 EXCELLENT ELITE INTERNATIONAL LTD come from?
All FDA import refusal data for EXCELLENT ELITE INTERNATIONAL 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.