XIAN TRIUMPH TECH CO LTD
⚠️ Moderate Risk
FEI: 3023889446 • Xi'An, Shaanxi • CHINA
FEI Number
3023889446
Location
Xi'An, Shaanxi
Country
CHINAAddress
Bldg 3 5th Fl, No 4955shangyuan Road, Xi'An, Shaanxi, 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/9/2022 | 79NRJULTRASOUND, SKIN PERMEATION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is XIAN TRIUMPH TECH CO LTD's FDA import refusal history?
XIAN TRIUMPH TECH CO LTD (FEI: 3023889446) has 1 FDA import refusal record(s) in our database, spanning from 11/9/2022 to 11/9/2022.
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. XIAN TRIUMPH TECH CO LTD's FEI number is 3023889446.
What types of violations has XIAN TRIUMPH TECH CO LTD received?
XIAN TRIUMPH TECH CO LTD 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 XIAN TRIUMPH TECH CO LTD come from?
All FDA import refusal data for XIAN TRIUMPH TECH 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.