IMPROVE CO.,LIMITED
⚠️ Moderate Risk
FEI: 3014253211 • Hong Kong, Hong Kong Island • HONG KONG
FEI Number
3014253211
Location
Hong Kong, Hong Kong Island
Country
HONG KONGAddress
3A/F Tung Mei Garden Tung Chung District Lantau Island, , Hong Kong, 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
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 IMPROVE CO.,LIMITED's FDA import refusal history?
IMPROVE CO.,LIMITED (FEI: 3014253211) has 2 FDA import refusal record(s) in our database, spanning from 2/17/2023 to 1/28/2025.
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. IMPROVE CO.,LIMITED's FEI number is 3014253211.
What types of violations has IMPROVE CO.,LIMITED received?
IMPROVE CO.,LIMITED has been cited for 1 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 IMPROVE CO.,LIMITED come from?
All FDA import refusal data for IMPROVE CO.,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.