Guangzhou Inkue Technology Co. Ltd
⚠️ Moderate Risk
FEI: 3004596403 • Guangzhou • CHINA
FEI Number
3004596403
Location
Guangzhou
Country
CHINAAddress
2f, No 6 Alley 5, NanBian Industrial, , Guangzhou, , 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 |
|---|---|---|---|
| 10/15/2012 | 79OHVFOCUSED ULTRASOUND FOR TISSUE HEAT OR MECHANICAL CELLULAR DISRUPTION | Seattle District Office (SEA-DO) | |
| 7/22/2010 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Seattle District Office (SEA-DO) | |
| 7/22/2010 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Seattle District Office (SEA-DO) | |
| 7/22/2010 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Guangzhou Inkue Technology Co. Ltd's FDA import refusal history?
Guangzhou Inkue Technology Co. Ltd (FEI: 3004596403) has 4 FDA import refusal record(s) in our database, spanning from 7/22/2010 to 10/15/2012.
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. Guangzhou Inkue Technology Co. Ltd's FEI number is 3004596403.
What types of violations has Guangzhou Inkue Technology Co. Ltd received?
Guangzhou Inkue Technology Co. 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 Guangzhou Inkue Technology Co. Ltd come from?
All FDA import refusal data for Guangzhou Inkue Technology Co. 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.