Epro E-Commerce Limited
✅ Low Risk
FEI: 3011682725 • Shatinshatin • HONG KONG
FEI Number
3011682725
Location
Shatinshatin
Country
HONG KONGAddress
Rm 301 3/F Town Health Technol, , Shatinshatin, , 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
Refusal History
Frequently Asked Questions
What is Epro E-Commerce Limited's FDA import refusal history?
Epro E-Commerce Limited (FEI: 3011682725) has 1 FDA import refusal record(s) in our database, spanning from 11/19/2015 to 11/19/2015.
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. Epro E-Commerce Limited's FEI number is 3011682725.
What types of violations has Epro E-Commerce Limited received?
Epro E-Commerce Limited 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 Epro E-Commerce Limited come from?
All FDA import refusal data for Epro E-Commerce Limited 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.