Xi'an Le Sen Bio-technology Co.,Ltd
⚠️ Moderate Risk
FEI: 3013330700 • Xian, Shanxi • CHINA
FEI Number
3013330700
Location
Xian, Shanxi
Country
CHINAAddress
Jinye-Shidai Building B1 Room 1401, Jinye Road; Yanta, Xian, 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
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 9/9/2021 | 54YAR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 3280FRNMFGREG | Division of Northern Border Imports (DNBI) |
| 6/17/2021 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 3/14/2018 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Division of Southeast Imports (DSEI) |
| 8/22/2017 | 41YYH99DIETARY CONVENTIONAL FOODS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Xi'an Le Sen Bio-technology Co.,Ltd's FDA import refusal history?
Xi'an Le Sen Bio-technology Co.,Ltd (FEI: 3013330700) has 4 FDA import refusal record(s) in our database, spanning from 8/22/2017 to 9/9/2021.
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 Le Sen Bio-technology Co.,Ltd's FEI number is 3013330700.
What types of violations has Xi'an Le Sen Bio-technology Co.,Ltd received?
Xi'an Le Sen Bio-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 Xi'an Le Sen Bio-technology Co.,Ltd come from?
All FDA import refusal data for Xi'an Le Sen Bio-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.