Well Brain Intl Ltd
✅ Low Risk
FEI: 3009293232 • Tsim Sha Tsui, Kowloon • HONG KONG
FEI Number
3009293232
Location
Tsim Sha Tsui, Kowloon
Country
HONG KONGAddress
1 Science Museum Road, , Tsim Sha Tsui, Kowloon, 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
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).
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.
Refusal History
Frequently Asked Questions
What is Well Brain Intl Ltd's FDA import refusal history?
Well Brain Intl Ltd (FEI: 3009293232) has 2 FDA import refusal record(s) in our database, spanning from 2/1/2012 to 2/1/2012.
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. Well Brain Intl Ltd's FEI number is 3009293232.
What types of violations has Well Brain Intl Ltd received?
Well Brain Intl Ltd has been cited for 2 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 Well Brain Intl Ltd come from?
All FDA import refusal data for Well Brain Intl 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.