HOKIN INDUSTRY CO., LTD.
⚠️ Moderate Risk
FEI: 3015655982 • Kwai Chung, New Territories • HONG KONG
FEI Number
3015655982
Location
Kwai Chung, New Territories
Country
HONG KONGAddress
Room 802, Wealthy Industrial Building; 22 Wing Yip Street, Kwai Chung, New Territories, 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
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/12/2021 | 98LCA99ELECTRONIC NICOTINE DELIVERY SYSTEM, NEC | Division of Southeast Imports (DSEI) | |
| 4/12/2021 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Northern Border Imports (DNBI) | |
| 8/31/2020 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is HOKIN INDUSTRY CO., LTD.'s FDA import refusal history?
HOKIN INDUSTRY CO., LTD. (FEI: 3015655982) has 3 FDA import refusal record(s) in our database, spanning from 8/31/2020 to 4/12/2021.
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. HOKIN INDUSTRY CO., LTD.'s FEI number is 3015655982.
What types of violations has HOKIN INDUSTRY CO., LTD. received?
HOKIN INDUSTRY 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 HOKIN INDUSTRY CO., LTD. come from?
All FDA import refusal data for HOKIN INDUSTRY 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.