EQUAL PROFIT LTD
⚠️ Moderate Risk
FEI: 3012846872 • Sheung Wan, Hong Kong Island • HONG KONG
FEI Number
3012846872
Location
Sheung Wan, Hong Kong Island
Country
HONG KONGAddress
7/F, Wui Tat Centre; 55 Connaught Road West, Sheung Wan, Hong Kong Island, 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
TP NO PMTA
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 FDA has found to be adulterated under section 902(6)(A) of the FD&C Act in that it does not have an FDA marketing order in effect under section 910(c)(1)(A)(i) of the FD&C Act.
TP NO SE
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 FDA has found to be misbranded under section 903(a)(6) of the FD&C Act in that a notice or other information respecting it was not provided as required by section 905(j).
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.
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.
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).
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."
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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 |
|---|---|---|---|
| 6/8/2021 | 98MAA03ENDS ATOMIZER | Division of West Coast Imports (DWCI) | |
| 6/8/2021 | 98MAA03ENDS ATOMIZER | Division of West Coast Imports (DWCI) | |
| 5/21/2021 | 98MAA03ENDS ATOMIZER | Division of Northern Border Imports (DNBI) | |
| 5/6/2021 | 98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC | Division of Southeast Imports (DSEI) | |
| 5/6/2021 | 98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC | Division of Southeast Imports (DSEI) | |
| 4/30/2021 | 98LCA11VAPE PEN | Division of West Coast Imports (DWCI) | |
| 12/5/2019 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is EQUAL PROFIT LTD's FDA import refusal history?
EQUAL PROFIT LTD (FEI: 3012846872) has 7 FDA import refusal record(s) in our database, spanning from 12/5/2019 to 6/8/2021.
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. EQUAL PROFIT LTD's FEI number is 3012846872.
What types of violations has EQUAL PROFIT LTD received?
EQUAL PROFIT LTD has been cited for 8 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 EQUAL PROFIT LTD come from?
All FDA import refusal data for EQUAL PROFIT 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.