Shaanxi Undersun Biomedtech Co.,Ltd
⚠️ Moderate Risk
FEI: 3014102096 • Xianyang, Shanxi • CHINA
FEI Number
3014102096
Location
Xianyang, Shanxi
Country
CHINAAddress
No. 2 AOKAI Rd., Industrial Park, Wugong County,, , Xianyang, Shanxi, 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
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
PESTICIDE2
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/13/2025 | 25SYH99FUNGI PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C. | 249FILTHY | Division of West Coast Imports (DWCI) |
| 6/13/2025 | 25SYH04MUSHROOM, SHIITAKE, FUNGI PRODUCTS, N.E.C. | 249FILTHY | Division of West Coast Imports (DWCI) |
| 12/18/2013 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shaanxi Undersun Biomedtech Co.,Ltd's FDA import refusal history?
Shaanxi Undersun Biomedtech Co.,Ltd (FEI: 3014102096) has 3 FDA import refusal record(s) in our database, spanning from 12/18/2013 to 6/13/2025.
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. Shaanxi Undersun Biomedtech Co.,Ltd's FEI number is 3014102096.
What types of violations has Shaanxi Undersun Biomedtech Co.,Ltd received?
Shaanxi Undersun Biomedtech Co.,Ltd has been cited for 5 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 Shaanxi Undersun Biomedtech Co.,Ltd come from?
All FDA import refusal data for Shaanxi Undersun Biomedtech 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.