Hung Chun Enterprise Co
✅ Low Risk
FEI: 3006002979 • Kwai Chung, New Territories • HONG KONG
FEI Number
3006002979
Location
Kwai Chung, New Territories
Country
HONG KONGAddress
115 Kwai Fung Crescent, , Kwai Chung, New Territories, Hong Kong
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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).
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
Frequently Asked Questions
What is Hung Chun Enterprise Co's FDA import refusal history?
Hung Chun Enterprise Co (FEI: 3006002979) has 1 FDA import refusal record(s) in our database, spanning from 2/16/2007 to 2/16/2007.
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. Hung Chun Enterprise Co's FEI number is 3006002979.
What types of violations has Hung Chun Enterprise Co received?
Hung Chun Enterprise Co 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 Hung Chun Enterprise Co come from?
All FDA import refusal data for Hung Chun Enterprise Co 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.