Custom Accessories Asia Ltd
✅ Low Risk
FEI: 3000178595 • Kowloon • HONG KONG
FEI Number
3000178595
Location
Kowloon
Country
HONG KONGAddress
67 Mody Road, , 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
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).
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 Custom Accessories Asia Ltd's FDA import refusal history?
Custom Accessories Asia Ltd (FEI: 3000178595) has 1 FDA import refusal record(s) in our database, spanning from 1/25/2003 to 1/25/2003.
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. Custom Accessories Asia Ltd's FEI number is 3000178595.
What types of violations has Custom Accessories Asia Ltd received?
Custom Accessories Asia 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 Custom Accessories Asia Ltd come from?
All FDA import refusal data for Custom Accessories Asia 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.