Xi'an Maxsun Bio&Tech Co., Ltd
⚠️ Moderate Risk
FEI: 3006682937 • Xi'An, Shaanxi • CHINA
FEI Number
3006682937
Location
Xi'An, Shaanxi
Country
CHINAAddress
NO. 18 South Dongguan Street, , 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
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.
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/22/2010 | 25SFY01MUSHROOM, COMMON (AGARICUS BISPORUS), FUNGI PRODUCTS, N.E.C. | 249FILTHY | Los Angeles District Office (LOS-DO) |
| 10/22/2010 | 25SFY04MUSHROOM, SHIITAKE, FUNGI PRODUCTS, N.E.C. | 249FILTHY | Los Angeles District Office (LOS-DO) |
| 10/22/2010 | 25SFY99FUNGI PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C. | 249FILTHY | Los Angeles District Office (LOS-DO) |
| 10/6/2010 | 25SGH01MUSHROOM, COMMON (AGARICUS BISPORUS), FUNGI PRODUCTS, N.E.C. | 249FILTHY | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 64LAR58PREGNENOLONE SUCCINATE (GLUCOCORTICOID) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/15/2009 | 63EAR18ADENOSINE (CARDIAC DEPRESSANT (ANTI-ARRHYTHMIC)) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/24/2008 | 66SAS40INOSITOL NIACINATE (VASODILATOR) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Xi'an Maxsun Bio&Tech Co., Ltd's FDA import refusal history?
Xi'an Maxsun Bio&Tech Co., Ltd (FEI: 3006682937) has 7 FDA import refusal record(s) in our database, spanning from 9/24/2008 to 10/22/2010.
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. Xi'an Maxsun Bio&Tech Co., Ltd's FEI number is 3006682937.
What types of violations has Xi'an Maxsun Bio&Tech Co., Ltd received?
Xi'an Maxsun Bio&Tech Co., Ltd has been cited for 4 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 Xi'an Maxsun Bio&Tech Co., Ltd come from?
All FDA import refusal data for Xi'an Maxsun Bio&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.