Design Go Asia Ltd
⚠️ Moderate Risk
FEI: 3009057828 • Hong Kong • CHINA
FEI Number
3009057828
Location
Hong Kong
Country
CHINAAddress
Rm 2301-2303, 23/F Metropolis Tower 10, , Hong Kong, , China
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
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/9/2016 | 84MVVDEVICE, ACUPRESSURE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/9/2016 | 84MVVDEVICE, ACUPRESSURE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/23/2015 | 84MVVDEVICE, ACUPRESSURE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/23/2015 | 84MVVDEVICE, ACUPRESSURE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/11/2014 | 84MVVDEVICE, ACUPRESSURE | Florida District Office (FLA-DO) | |
| 3/12/2014 | 84MVVDEVICE, ACUPRESSURE | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 4/8/2013 | 84MVVDEVICE, ACUPRESSURE | Division of Southeast Imports (DSEI) | |
| 1/7/2013 | 84MVVDEVICE, ACUPRESSURE | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Design Go Asia Ltd's FDA import refusal history?
Design Go Asia Ltd (FEI: 3009057828) has 8 FDA import refusal record(s) in our database, spanning from 1/7/2013 to 3/9/2016.
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. Design Go Asia Ltd's FEI number is 3009057828.
What types of violations has Design Go Asia Ltd received?
Design Go Asia Ltd 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 Design Go Asia Ltd come from?
All FDA import refusal data for Design Go 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.